Research Publications

Overcoming interference with the detection of a stable isotopically labeled microtracer in the evaluation of beclabuvir absolute bioavailability using a concomitant microtracer approach.

Jiang H, Titsch C, Zeng J, Jones B, Joyce P, Gandhi Y, Turley W, Burrell R, Aubry AF, Arnold ME.

J Pharm Biomed Anal. 2017 Sep 5;143:9-16. doi: 10.1016/j.jpba.2017.04.030. Epub 2017 May 17.

PMID: 28544885

 

Impact of moisture and magnesium stearate functionality on manufacturability of wet granulated metformin tablets.

Kestur U, Desai D, Sharif S, Wong B, Guo H, Tang D, Chan S.

Pharm Dev Technol. 2017 Sep;22(6):715-723. doi: 10.3109/10837450.2015.1116562. Epub 2015 Nov 29.

PMID: 26616157

 

Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users: analysis of patient electronic medical record data.

Rosenblatt L, Broder MS, Bentley TGK, Chang E, Reddy SR, Papoyan E, Myers J.

AIDS Care. 2017 Aug;29(8):1067-1073. doi: 10.1080/09540121.2017.1280123. Epub 2017 Feb 1.

PMID: 28147708

 

A multiplexed immunocapture liquid chromatography tandem mass spectrometry assay for the simultaneous measurement of myostatin and GDF-11 in rat serum using an automated sample preparation platform.

Zhao Y, Liu G, Zambito FC, Zhang YJ, DeSilva BS, Kozhich AT, Shen JX.

Anal Chim Acta. 2017 Aug 1;979:36-44. doi: 10.1016/j.aca.2017.04.028. Epub 2017 Apr 26.

PMID: 28599707

 

Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios.

Saglio G, le Coutre P, Cortes J, Mayer J, Rowlings P, Mahon FX, Kroog G, Gooden K, Subar M, Shah NP.

Ann Hematol. 2017 Aug;96(8):1303-1313. doi: 10.1007/s00277-017-3012-z. Epub 2017 May 22.

PMID: 28534184

 

Discovery of BMS-961955, an allosteric inhibitor of the hepatitis C virus NS5B polymerase.

Zheng BZ, D'Andrea SV, Hanumegowda U, Knipe JO, Mosure K, Zhuo X, Lemm JA, Liu M, Rigat KL, Wang YK, Fang H, Poronsky C, Cutrone J, Wu DR, Arunachalam PN, Balapragalathan TJ, Arumugam A, Mathur A, Meanwell NA, Gao M, Roberts SB, Kadow JF.

Bioorg Med Chem Lett. 2017 Aug 1;27(15):3294-3300. doi: 10.1016/j.bmcl.2017.06.024. Epub 2017 Jun 11.

PMID: 28633899

 

Role of regional absorption and gastrointestinal motility on variability in oral absorption of a model drug.

Narang AS, Balakrishnan A, Morrison J, Li J, Wang J, Gu H, Taylor K, Santone K, Ehrmann J, Beyer S, Lu X, Ketner R, Pizzano J, Orcutt T, Shields E, Dulac H, Aborn S, Batchelder M, Lentz K.

Eur J Pharm Biopharm. 2017 Aug;117:333-345. doi: 10.1016/j.ejpb.2017.04.026. Epub 2017 Apr 25.

PMID: 28455207

 

Lipophilic salts of poorly soluble compounds to enable high-dose lipidic SEDDS formulations in drug discovery.

Morgen M, Saxena A, Chen XQ, Miller W, Nkansah R, Goodwin A, Cape J, Haskell R, Su C, Gudmundsson O, Hageman M, Kumar A, Chowan GS, Rao A, Holenarsipur VK.

Eur J Pharm Biopharm. 2017 Aug;117:212-223. doi: 10.1016/j.ejpb.2017.04.021. Epub 2017 Apr 21.

PMID: 28438550

 

A quantitative in silico model for predicting skin sensitization using a nearest neighbours approach within expert-derived structure-activity alert spaces.

Canipa SJ, Chilton ML, Hemingway R, Macmillan DS, Myden A, Plante JP, Tennant RE, Vessey JD, Steger-Hartmann T, Gould J, Hillegass J, Etter S, Smith BPC, White A, Sterchele P, De Smedt A, O'Brien D, Parakhia R.

J Appl Toxicol. 2017 Aug;37(8):985-995. doi: 10.1002/jat.3448. Epub 2017 Feb 28.

 

Influence of Meals and Glycemic Changes on QT Interval Dynamics.

Cirincione B, Sager PT, Mager DE.

J Clin Pharmacol. 2017 Aug;57(8):966-976. doi: 10.1002/jcph.933. Epub 2017 May 22.

PMID: 28543601

 

Model-Based Evaluation of Exenatide Effects on the QT Interval in Healthy Subjects Following Continuous IV Infusion.

Cirincione B, LaCreta F, Sager P, Mager DE.

J Clin Pharmacol. 2017 Aug;57(8):956-965. doi: 10.1002/jcph.882. Epub 2017 May 22.

PMID: 28543393

 

Discovery of potent and efficacious pyrrolopyridazines as dual JAK1/3 inhibitors.

Hynes J Jr, Wu H, Kempson J, Duan JJ, Lu Z, Jiang B, Stachura S, Tokarski JS, Sack JS, Khan JA, Lippy JS, Zhang RF, Pitt S, Shen G, Gillooly K, McIntyre K, Carter PH, Barrish JC, Nadler SG, Salter-Cid LM, Fura A, Schieven GL, Pitts WJ, Wrobleski ST.

Bioorg Med Chem Lett. 2017 Jul 15;27(14):3101-3106. doi: 10.1016/j.bmcl.2017.05.043. Epub 2017 May 15.

PMID: 28539220

 

Effects of BMS-902483, an α7 nicotinic acetylcholine receptor partial agonist, on cognition and sensory gating in relation to receptor occupancy in rodents.

Pieschl RL, Miller R, Jones KM, Post-Munson DJ, Chen P, Newberry K, Benitex Y, Molski T, Morgan D, McDonald IM, Macor JE, Olson RE, Asaka Y, Digavalli S, Easton A, Herrington J, Westphal RS, Lodge NJ, Zaczek R, Bristow LJ, Li YW.

Eur J Pharmacol. 2017 Jul 15;807:1-11. doi: 10.1016/j.ejphar.2017.04.024. Epub 2017 Apr 22.

PMID: 28438647

 

Identification of a host cell protein impurity in therapeutic protein, P1.

Ahluwalia D, Dhillon H, Slaney T, Song H, Boux H, Mehta S, Zhang L, Valdez A, Krishnamurthy G.

J Pharm Biomed Anal. 2017 Jul 15;141:32-38. doi: 10.1016/j.jpba.2017.03.065. Epub 2017 Apr 9.

PMID:28419935

 

LC-MS determination of triazolam and its hydroxy metabolites in mouse dried blood spots: application to transgenic mouse pharmacokinetic studies.

Kole P, Rao A, Kurawattimath V, Mandlekar S.

Bioanalysis. 2017 Jul 10. doi: 10.4155/bio-2017-0067. [Epub ahead of print]

PMID: 28692308

 

Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes.

Wysham CH, Rosenstock J, Vetter ML, Dong F, Öhman P, Iqbal N.

Diabetes Obes Metab. 2017 Jul 7. doi: 10.1111/dom.13056. [Epub ahead of print]

PMID: 28685973

 

Utilization of an Active Site Mutant Receptor for the Identification of Potent and Selective Atypical 5-HT_2C Receptor Agonists.

Carpenter J, Wang Y, Wu G, Feng J, Ye XY, Morales CL, Broekema M, Rossi KA, Miller KJ, Murphy BJ, Wu G, Malmstrom SE, Azzara AV, Sher PM, Fevig JM, Alt A, Bertekap RL Jr, Cullen MJ, Harper TM, Foster K, Luk E, Xiang Q, Grubb MF, Robl JA, Wacker DA.

J Med Chem. 2017 Jul 7. doi: 10.1021/acs.jmedchem.7b00385. [Epub ahead of print]

PMID: 28635286

 

Improving Robustness: In Situ Generation of a Pd(0) Catalyst for the Cyanation of Aryl Bromides.

Coombs JR, Fraunhoffer KJ, Simmons EM, Stevens JM, Wisniewski SR, Yu M.

J Org Chem. 2017 Jul 7;82(13):7040-7044. doi: 10.1021/acs.joc.7b01003. Epub 2017 Jun 22.

PMID: 28594174

 

Orthogonal Mass Spectrometry-Based Footprinting for Epitope Mapping and Structural Characterization: The IL-6 Receptor upon Binding of Protein Therapeutics.

Li KS, Chen G, Mo J, Huang RY, Deyanova EG, Beno BR, O'Neil SR, Tymiak AA, Gross ML.

Anal Chem. 2017 Jul 6. doi: 10.1021/acs.analchem.7b01748. [Epub ahead of print]

PMID: 28621526

 

Integrating cytokines and angiogenic factors and tumour bulk with selected clinical criteria improves determination of prognosis in advanced renal cell carcinoma.

Zurita AJ, Gagnon RC, Liu Y, Tran HT, Figlin RA, Hutson TE, D'Amelio AM Jr, Sternberg CN, Pandite LN, Heymach JV.

Br J Cancer. 2017 Jul 6. doi: 10.1038/bjc.2017.206. [Epub ahead of print]

PMID: 28683470

 

Risk of major bleeding in patients with non-valvular atrial fibrillation treated with oral anticoagulants: a systematic review of real-world observational studies.

Deitelzweig S, Farmer C, Luo X, Vo L, Li X, Hamilton M, Horblyuk R, Ashaye A.

Curr Med Res Opin. 2017 Jul 6:1-12. doi: 10.1080/03007995.2017.1347090. [Epub ahead of print]

PMID: 28644048

 

Synergistic inhibition of Aβ production by combinations of γ-secretase modulators.

Robertson AS, Iben LG, Wei C, Meredith JE Jr, Drexler DM, Banks M, Vite GD, Olson RE, Thompson LA, Albright CF, Ahlijanian MK, Toyn JH.

Eur J Pharmacol. 2017 Jul 6. pii: S0014-2999(17)30457-0. doi: 10.1016/j.ejphar.2017.07.019. [Epub ahead of print]

PMID: 28690193

 

Evaluation of healthcare resource utilization and incremental economic burden of patients with chronic myeloid leukemia after disease progression to blast phase.

Jabbour EJ, Lin J, Siegartel LR, Lingohr-Smith M, Menges B, Makenbaeva D.

J Med Econ. 2017 Jul 6:1-6. doi: 10.1080/13696998.2017.1345750. [Epub ahead of print]

PMID: 28681664

 

Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.

Chang RK, Mathias N, Hussain MA.

AAPS J. 2017 Jul 5. doi: 10.1208/s12248-017-0112-6. [Epub ahead of print]

PMID: 28681160

 

Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth.

Dimopoulos MA, Lonial S, White D, Moreau P, Palumbo A, San-Miguel J, Shpilberg O, Anderson K, Grosicki S, Spicka I, Walter-Croneck A, Magen H, Mateos MV, Belch A, Reece D, Beksac M, Bleickardt E, Poulart V, Sheng J, Sy O, Katz J, Singhal A, Richardson P.

Br J Haematol. 2017 Jul 5. doi: 10.1111/bjh.14787. [Epub ahead of print]

PMID: 28677826

 

Silent Allosteric Modulation of mGluR5 Maintains Glutamate Signaling while Rescuing Alzheimer's Mouse Phenotypes.

Haas LT, Salazar SV, Smith LM, Zhao HR, Cox TO, Herber CS, Degnan AP, Balakrishnan A, Macor JE, Albright CF, Strittmatter SM.

Cell Rep. 2017 Jul 5;20(1):76-88. doi: 10.1016/j.celrep.2017.06.023.

PMID: 28683325

 

Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study.

Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Lewis LD, Voss MH, Sharma P, Pal SK, Razak ARA, Kollmannsberger C, Heng DYC, Spratlin J, McHenry MB, Amin A.

J Clin Oncol. 2017 Jul 5:JCO2016721985. doi: 10.1200/JCO.2016.72.1985. [Epub ahead of print]

PMID: 28678668

 

Zinc Acetate-Promoted Buchwald-Hartwig Couplings of Heteroaromatic Amines.

Ayothiraman R, Rangaswamy S, Maity P, Simmons EM, Beutner GL, Janey J, Treitler DS, Eastgate MD, Vaidyanathan R.

J Org Chem. 2017 Jul 5. doi: 10.1021/acs.joc.7b01101. [Epub ahead of print]

PMID: 28677970

 

Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial.

Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J.

J Clin Oncol. 2017 Jul 3:JCO2016718023. doi: 10.1200/JCO.2016.71.8023. [Epub ahead of print]

PMID: 28671856

 

QSP Toolbox: Computational Implementation of Integrated Workflow Components for Deploying Multi-Scale Mechanistic Models.

Cheng Y, Thalhauser CJ, Smithline S, Pagidala J, Miladinov M, Vezina HE, Gupta M, Leil TA, Schmidt BJ.

AAPS J. 2017 Jul;19(4):1002-1016. doi: 10.1208/s12248-017-0100-x. Epub 2017 May 24.

PMID: 28540623

 

Identification of highly potent and selective PI3Kδ inhibitors.

Marcoux D, Qin LY, Ruan Z, Shi Q, Ruan Q, Weigelt C, Qiu H, Schieven G, Hynes J, Bhide R, Poss M, Tino J.

Bioorg Med Chem Lett. 2017 Jul 1;27(13):2849-2853. doi: 10.1016/j.bmcl.2017.01.077. Epub 2017 Feb 7.

PMID: 28209465

 

Delays in treatment intensification with oral antidiabetic drugs and risk of microvascular and macrovascular events in patients with poor glycaemic control: An individual patient simulation study.

Folse HJ, Mukherjee J, Sheehan JJ, Ward AJ, Pelkey RL, Dinh TA, Qin L, Kim J.

Diabetes Obes Metab. 2017 Jul;19(7):1006-1013. doi: 10.1111/dom.12913. Epub 2017 Mar 20.

PMID: 28211604

 

Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study.

Gadde KM, Vetter ML, Iqbal N, Hardy E, Öhman P; DURATION-NEO-2 study investigators.

Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.

PMID: 28205322

 

Economic Outcomes of First-Line Regimen Switching Among Stable Patients with HIV.

Rosenblatt L, Buikema AR, Seare J, Bengtson LGS, Johnson J, Cao F, Villasis-Keever A.

J Manag Care Spec Pharm. 2017 Jul;23(7):725-734. doi: 10.18553/jmcp.2017.16403. Epub 2017 Jun 5.

PMID: 28650246

 

Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.

Saint-Laurent Thibault C, Moorjaney D, Ganz ML, Sill B, Hede S, Yuan Y, Gorsh B.

J Med Econ. 2017 Jul;20(7):692-702. doi: 10.1080/13696998.2017.1307204. Epub 2017 Apr 20.

PMID: 28294645

 

Healthcare and economic burden of adverse events among patients with chronic myelogenous leukemia treated with BCR-ABL1 tyrosine kinase inhibitors.

Lin J, Makenbaeva D, Lingohr-Smith M, Bilmes R.

J Med Econ. 2017 Jul;20(7):687-691. doi: 10.1080/13696998.2017.1302947. Epub 2017 Mar 12.

PMID: 28287043

 

Microbiota metabolite short-chain fatty acid acetate promotes intestinal IgA response to microbiota which is mediated by GPR43.

Wu W, Sun M, Chen F, Cao AT, Liu H, Zhao Y, Huang X, Xiao Y, Yao S, Zhao Q, Liu Z, Cong Y.

Mucosal Immunol. 2017 Jul;10(4):946-956. doi: 10.1038/mi.2016.114. Epub 2016 Dec 14.

PMID: 27966553

 

Dramatic elevation in urinary amino terminal titin fragment excretion quantified by immunoassay in Duchenne muscular dystrophy patients and in dystrophin deficient rodents.

Robertson AS, Majchrzak MJ, Smith CM, Gagnon RC, Devidze N, Banks GB, Little SC, Nabbie F, Bounous DI, DiPiero J, Jacobsen LK, Bristow LJ, Ahlijanian MK, Stimpson SA.

Neuromuscul Disord. 2017 Jul;27(7):635-645. doi: 10.1016/j.nmd.2017.05.009. Epub 2017 May 12.

PMID: 28554556

 

Cost per response for abatacept versus adalimumab in rheumatoid arthritis by ACPA subgroups in Germany, Italy, Spain, US and Canada.

Weijers L, Baerwald C, Mennini FS, Rodríguez-Heredia JM, Bergman MJ, Choquette D, Herrmann KH, Attinà G, Nappi C, Merino SJ, Patel C, Mtibaa M, Foo J.

Rheumatol Int. 2017 Jul;37(7):1111-1123. doi: 10.1007/s00296-017-3739-9. Epub 2017 May 30.

PMID: 28560470

 

The synthesis of [₁₄ C]4-acetylphenylalanine, effect on cell viability, and assessment of protein incorporation in male rat hepatocytes.

Maxwell BD, Ly V, Brock B, Dodge R, Tirmenstein M, Calvano J.

J Labelled Comp Radiopharm. 2017 Jun 30;60(8):352-356. doi: 10.1002/jlcr.3499. Epub 2017 May 30.

PMID: 28273378

 

The syntheses of [₁₃ C₆ ] and [phenyl-₁₄ C(U)]BMS-816336, an inhibitor of 11β-hydroxysteroid dehydrogenase type 1, for type 2 diabetes.

Maxwell BD.

J Labelled Comp Radiopharm. 2017 Jun 30;60(8):357-365. doi: 10.1002/jlcr.3500. Epub 2017 May 30.

PMID: 28273377

 

Self-Assembling Cyclic d,l-α-Peptides as Modulators of Plasma HDL Function. A Supramolecular Approach toward Antiatherosclerotic Agents.

Zhao Y, Leman LJ, Search DJ, Garcia RA, Gordon DA, Maryanoff BE, Ghadiri MR.

ACS Cent Sci. 2017 Jun 28;3(6):639-646. doi: 10.1021/acscentsci.7b00154. Epub 2017 Jun 13.

PMID: 28691076

 

Efficacy of Sequential Ipilimumab Monotherapy vs Best Supportive Care For Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer.

Bang YJ, Cho JY, Kim YH, Kim JW, Di Bartolomeo M, Ajani JA, Yamaguchi K, Balogh A, Sanchez T, Moehler M.

Clin Cancer Res. 2017 Jun 27. pii: clincanres.0025.2017. doi: 10.1158/1078-0432.CCR-17-0025. [Epub ahead of print]

PMID: 28655793

 

Integrating a post-column makeup pump into preparative supercritical fluid chromatography systems to address stability and recovery issues during purifications.

Bajpai L, Naidu H, Asokan K, Shaik KM, Kaspady M, Arunachalam PN, Wu DR, Mathur A, Sarabu R.

J Chromatogr A. 2017 Jun 27. pii: S0021-9673(17)30953-6. doi: 10.1016/j.chroma.2017.06.063. [Epub ahead of print]

PMID: 28687240

 

Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial.

El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I.

Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

PMID: 28434648

Macrocyclic inhibitors of Factor XIa: Discovery of alkyl-substituted macrocyclic amide linkers with improved potency.

Corte JR, Yang W, Fang T, Wang Y, Osuna H, Lai A, Ewing WR, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Zheng JJ, Harper TW, Bozarth JM, Wu Y, Luettgen JM, Seiffert DA, Quan ML, Wexler RR, Lam PYS.

Bioorg Med Chem Lett. 2017 Jun 23. pii: S0960-894X(17)30660-1. doi: 10.1016/j.bmcl.2017.06.058. [Epub ahead of print]

PMID: 28687203

 

Developing a Natural History Progression Model for Duchenne Muscular Dystrophy using the Six Minute Walk Test.

Hamuro L, Chan P, Tirucherai G, AbuTarif M.

CPT Pharmacometrics Syst Pharmacol. 2017 Jun 23. doi: 10.1002/psp4.12220. [Epub ahead of print]

PMID: 28643370

 

Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time.

Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindbäck J, Granger CB, Alexander JH, Gersh BJ, Hanna M, Harjola VP, Hylek EM, Lopes RD, Siegbahn A, Wallentin L.

J Am Heart Assoc. 2017 Jun 23;6(6). pii: e004851. doi: 10.1161/JAHA.116.004851.

PMID: 28645934

 

Bile salt homeostasis in normal and Bsep gene knock out rats with single and repeated doses of troglitazone.

Cheng Y, Chen S, Freeden C, Chen W, Zhang Y, Abraham P, Nelson D, Humphreys WG, Gan J, Lai Y.

J Pharmacol Exp Ther. 2017 Jun 23. pii: jpet.117.242370. doi: 10.1124/jpet.117.242370. [Epub ahead of print]

PMID: 28645914

 

Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial.

Harrington KJ, Ferris RL, Blumenschein G Jr, Colevas AD, Fayette J, Licitra L, Kasper S, Even C, Vokes EE, Worden F, Saba NF, Kiyota N, Haddad R, Tahara M, Grünwald V, Shaw JW, Monga M, Lynch M, Taylor F, DeRosa M, Morrissey L, Cocks K, Gillison ML, Guigay J.

Lancet Oncol. 2017 Jun 23. pii: S1470-2045(17)30421-7. doi: 10.1016/S1470-2045(17)30421-7. [Epub ahead of print]

PMID: 28651929

 

A functional NaV1.7-NavAb chimera with a reconstituted high affinity ProTx-II binding site.

Rajamani R, Wu S, Rodrigo I, Gao M, Low S, Megson L, Wensel D, Pieschl R, Post-Munson D, Watson J, Langley DR, Ahlijanian M, Bristow L, Herrington J.

Mol Pharmacol. 2017 Jun 23. pii: mol.117.108712. doi: 10.1124/mol.117.108712. [Epub ahead of print]

PMID: 28645932

 

Health-related quality of life results from the phase III CheckMate 067 study.

Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV.

Eur J Cancer. 2017 Jun 22;82:80-91. doi: 10.1016/j.ejca.2017.05.031. [Epub ahead of print]

PMID: 28651159

 

Identification of a Potent, Selective, and Efficacious Phosphatidylinositol 3-Kinase δ (PI3Kδ) Inhibitor for the Treatment of Immunological Disorders.

Liu Q, Shi Q, Marcoux D, Batt DG, Cornelius L, Qin LY, Ruan Z, Neels J, Beaudoin-Bertrand M, Srivastava AS, Li L, Cherney RJ, Gong H, Watterson SH, Weigelt C, Gillooly KM, McIntyre KW, Xie JH, Obermeier MT, Fura A, Sleczka B, Stefanski K, Fancher RM, Padmanabhan S, Rp T, Kundu I, Rajareddy K, Smith R, Hennan JK, Xing D, Fan J, Levesque PC, Ruan Q, Pitt S, Zhang R, Pedicord D, Pan J, Yarde M, Lu H, Lippy J, Goldstine C, Skala S, Rampulla RA, Mathur A, Gupta A, Arunachalam PN, Sack JS, Muckelbauer JK, Cvijic ME, Salter-Cid LM, Bhide RS, Poss MA, Hynes J, Carter PH, Macor JE, Ruepp S, Schieven GL, Tino JA.

J Med Chem. 2017 Jun 22;60(12):5193-5208. doi: 10.1021/acs.jmedchem.7b00618. Epub 2017 Jun 5.

PMID: 28541707

 

Discovery of Clinical Candidate 2-((2S,6S)-2-Phenyl-6-hydroxyadamantan-2-yl)-1-(3'-hydroxyazetidin-1-yl)ethanone [BMS-816336], an Orally Active Novel Selective 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor.

Ye XY, Chen SY, Wu S, Yoon DS, Wang H, Hong Z, O'Connor SP, Li J, Li JJ, Kennedy LJ, Walker SJ, Nayeem A, Sheriff S, Camac DM, Ramamurthy V, Morin PE, Zebo R, Taylor JR, Morgan NN, Ponticiello RP, Harrity T, Apedo A, Golla R, Seethala R, Wang M, Harper TW, Sleczka BG, He B, Kirby M, Leahy DK, Li J, Hanson RL, Guo Z, Li YX, DiMarco JD, Scaringe R, Maxwell B, Moulin F, Barrish JC, Gordon DA, Robl JA.

J Med Chem. 2017 Jun 22;60(12):4932-4948. doi: 10.1021/acs.jmedchem.7b00211. Epub 2017 Jun 5.

PMID: 28537398

 

Major bleeding risk and healthcare economic outcomes of non-valvular atrial fibrillation patients newly-initiated with oral anticoagulant therapy in the real-world setting.

Lin J, Trocio J, Gupta K, Mardekian J, Lingohr-Smith M, Menges B, You M, Nadkarni A.

J Med Econ. 2017 Jun 22:1-10. doi: 10.1080/13696998.2017.1341902. [Epub ahead of print]

PMID: 28604139

 

First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.

Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators.

N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

PMID: 28636851

 

Risk of stroke/systemic embolism, major bleeding and associated costs in non-valvular atrial fibrillation patients who initiated apixaban, dabigatran, or rivaroxaban compared with warfarin in the United States Medicare population.

Amin A, Keshishian A, Trocio J, Dina O, Le H, Rosenblatt L, Liu X, Mardekian J, Zhang Q, Baser O, Vo L.

Curr Med Res Opin. 2017 Jun 21:1-32. doi: 10.1080/03007995.2017.1345729. [Epub ahead of print]

PMID: 28635338

 

New Cancer Immunotherapy Agents in Development: a report from an associated program of the 31_stAnnual Meeting of the Society for Immunotherapy of Cancer, 2016.

Adusumilli PS, Cha E, Cornfeld M, Davis T, Diab A, Dubensky TW Jr, Evans E, Grogan JL, Irving BA, Leidner RS, Olwill SA, Soon-Shiong P, Triebel F, Tuck D, Bot A, Dansey RD, Drake CG, Freeman GJ, Ibrahim R, Patel S, Chen DS.

J Immunother Cancer. 2017 Jun 20;5:50. doi: 10.1186/s40425-017-0253-2. eCollection 2017. Review.

PMID: 28649381

 

Mapping the Binding Interface in a Non-covalent Size Variant of a Monoclonal Antibody Using Native Mass Spectrometry, Hydrogen/deuterium Exchange Mass Spectrometry and Computational Analysis.

Yan Y, Wei H, Jusuf S, Krystek SR Jr, Chen J, Chen G, Ludwig RT, Tao L, Das TK.

J Pharm Sci. 2017 Jun 17. pii: S0022-3549(17)30446-X. doi: 10.1016/j.xphs.2017.06.009. [Epub ahead of print]

PMID: 28634122

 

A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples.

Kavita U, Duo J, Crawford SM, Liu R, Valcin J, Gleason C, Dong H, Gadkari S, Dodge RW, Pillutla RC, DeSilva BS.

J Immunol Methods. 2017 Jun 16. pii: S0022-1759(17)30242-9. doi: 10.1016/j.jim.2017.06.002. [Epub ahead of print]

PMID: 28625864

 

A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays.

Li R, Cai W, Zocher M.

PDA J Pharm Sci Technol. 2017 Jun 16. pii: pdajpst.2016.007369. doi: 10.5731/pdajpst.2016.007369. [Epub ahead of print]

PMID: 28624777

 

Clinical Efficacy and Post-Treatment Seromarkers Associated with the Risk of Hepatocellular Carcinoma among Chronic Hepatitis C Patients.

Lee MH, Huang CF, Lai HC, Lin CY, Dai CY, Liu CJ, Wang JH, Huang JF, Su WP, Yang HC, Kee KM, Yeh ML, Chuang PH, Hsu SJ, Huang CI, Kao JT, Chen CC, Chen SH, Jeng WJ, Yang HI, Yuan Y, Lu SN, Sheen IS, Liu CH, Peng CY, Kao JH, Yu ML, Chuang WL, Chen CJ.

Sci Rep. 2017 Jun 16;7(1):3718. doi: 10.1038/s41598-017-02313-y.

PMID: 28623331

 

Neutral macrocyclic factor VIIa inhibitors.

Wurtz NR, Parkhurst BL, DeLucca I, Glunz PW, Jiang W, Zhang X, Cheney DL, Bozarth JM, Rendina AR, Wei A, Harper T, Luettgen JM, Wu Y, Wong PC, Seiffert DA, Wexler RR, Priestley ES.

Bioorg Med Chem Lett. 2017 Jun 15;27(12):2650-2654. doi: 10.1016/j.bmcl.2017.04.008. Epub 2017 Apr 19.

PMID: 28460818

 

The Humanistic Burden of Small Cell Lung Cancer (SCLC): A Systematic Review of Health-Related Quality of Life (HRQoL) Literature.

Bennett BM, Wells JR, Panter C, Yuan Y, Penrod JR.

Front Pharmacol. 2017 Jun 15;8:339. doi: 10.3389/fphar.2017.00339. eCollection 2017. Review.

PMID: 28663730

 

Comparative analysis of primary versus relapse/refractory DLBCL identifies shifts in mutation spectrum.

Greenawalt DM, Liang WS, Saif S, Johnson J, Todorov P, Dulak A, Enriquez D, Halperin R, Ahmed A, Saveliev V, Carpten J, Craig D, Barrett JC, Dougherty B, Zinda M, Fawell S, Dry JR, Byth K.

Oncotarget. 2017 Jun 15. doi: 10.18632/oncotarget.18502. [Epub ahead of print]

PMID: 28644138

 

NMR in drug design.

Harner MJ, Mueller L, Robbins KJ, Reily MD.

Arch Biochem Biophys. 2017 Jun 13. pii: S0003-9861(17)30364-8. doi: 10.1016/j.abb.2017.06.005. [Epub ahead of print]

PMID: 28619618

 

Assessment of programmed death-ligand 1 expression and tumor-associated immune cells in pediatric cancer tissues.

Majzner RG, Simon JS, Grosso JF, Martinez D, Pawel BR, Santi M, Merchant MS, Geoerger B, Hezam I, Marty V, Vielh P, Daugaard M, Sorensen PH, Mackall CL, Maris JM.

Cancer. 2017 Jun 13. doi: 10.1002/cncr.30724. [Epub ahead of print]

PMID: 28608950

 

The Impact of Disintegrant Type, Surfactant, and API Properties on the Processability and Performance of Roller Compacted Formulations of Acetaminophen and Aspirin.

Zhao J, Koo O, Pan D, Wu Y, Morkhade D, Rana S, Saha P, Marin A.

AAPS J. 2017 Jun 12. doi: 10.1208/s12248-017-0104-6. [Epub ahead of print]

PMID: 28608238

 

The Surprising Importance of Peptide Bond Contacts in Drug-Protein Interactions.

Parrish RM, Sitkoff DF, Cheney DL, Sherrill CD.

Chemistry. 2017 Jun 12;23(33):7887-7890. doi: 10.1002/chem.201701031. Epub 2017 May 23.

PMID: 28378374

 

Pooled analysis of HCV genotype 1 resistance-associated substitutions in NS5A, NS3 and NS5B pre- and post-treatment with 12 weeks of daclatasvir, asunaprevir and beclabuvir.

McPhee F, Hernandez D, Zhou N, Ueland J, Yu F, Vellucci V, Huang X, Wang X, Ishikawa H, Karino Y, Kumada H.

Antivir Ther. 2017 Jun 8. doi: 10.3851/IMP3177. [Epub ahead of print]

PMID: 28594332

 

High-Throughput Automation in Chemical Process Development.

Selekman JA, Qiu J, Tran K, Stevens J, Rosso V, Simmons E, Xiao Y, Janey J.

Annu Rev Chem Biomol Eng. 2017 Jun 7;8:525-547. doi: 10.1146/annurev-chembioeng-060816-101411. Epub 2017 May 1.

PMID: 28460183

 

Multivariate Analysis and Statistics in Pharmaceutical Process Research and Development.

Tabora JE, Domagalski N.

Annu Rev Chem Biomol Eng. 2017 Jun 7;8:403-426. doi: 10.1146/annurev-chembioeng-060816-101418. Epub 2017 Apr 17.

PMID: 28415862

 

Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.

Jiang H, Kozhich A, Cummings J, Gambardella J, Zambito F, Titsch C, Haulenbeek J, Phillips K, Fergus R, Myler H.

AAPS J. 2017 Jun 6. doi: 10.1208/s12248-017-0105-5. [Epub ahead of print]

PMID: 28589510

 

One Filter, One Sample, and the N- and O-Glyco(proteo)me: Toward a System to Study Disorders of Protein Glycosylation.

Skeene K, Walker M, Clarke G, Bergström E, Genever P, Ungar D, Thomas-Oates J.

Anal Chem. 2017 Jun 6;89(11):5840-5849. doi: 10.1021/acs.analchem.7b00143. Epub 2017 May 10.

PMID: 28453257

 

Discovery and Characterization of a Novel CD4-Binding Adnectin with Potent Anti-HIV Activity.

Wensel D, Sun Y, Li Z, Zhang S, Picarillo C, McDonagh T, Fabrizio D, Cockett M, Krystal M, Davis J.

Antimicrob Agents Chemother. 2017 Jun 5. pii: AAC.00508-17. doi: 10.1128/AAC.00508-17. [Epub ahead of print]

PMID: 28584151

 

Effects of Mild to Severe Hepatic Impairment on the Pharmacokinetics of Sonidegib: A Multicenter, Open-Label, Parallel-Group Study.

Horsmans Y, Zhou J, Liudmila M, Golor G, Shibolet O, Quinlan M, Emotte C, Boss H, Castro H, Sellami D, Preston RA.

Clin Pharmacokinet. 2017 Jun 2. doi: 10.1007/s40262-017-0560-2. [Epub ahead of print]

PMID: 28577129

 

Comparative Evaluation of Plasma Bile Acids, Dehydroepiandrosterone Sulfate, Hexadecanedioate and Tetradecanedioate with Coproporphyrins I and III as Markers of OATP Inhibition in Healthy Subjects.

Shen H, Chen W, Drexler DM, Mandlekar S, Holenarsipur VK, Shields EE, Langish R, Sidik K, Gan J, Humphreys WG, Marathe P, Lai Y.

Drug Metab Dispos. 2017 Jun 2. pii: dmd.117.075531. doi: 10.1124/dmd.117.075531. [Epub ahead of print]

PMID: 28576766

 

Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in "real-world" clinical practice. A propensity-matched analysis of 76,940 patients.

Li XS, Deitelzweig S, Keshishian A, Hamilton M, Horblyuk R, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Lip GYH.

Thromb Haemost. 2017 Jun 2;117(6):1072-1082. doi: 10.1160/TH17-01-0068. Epub 2017 Mar 16.

PMID: 28300870

 

Understanding the Impact of Chemical Variability and Calibration Algorithms on Prediction of Solid Fraction of Roller Compacted Ribbons Using Near-Infrared (NIR) Spectroscopy.

Talwar S, Nunes C, Stevens T, Nesarikar V, Timmins P, Anderson CA, Drennen JK 3rd.

Appl Spectrosc. 2017 Jun;71(6):1209-1221. doi: 10.1177/0003702816671960. Epub 2016 Nov 4.

PMID: 27815436

 

Affinity extraction LC-MS for small-molecule drug quantification: considerations, challenges and potential applications.

Mehl JT.

Bioanalysis. 2017 Jun;9(11):845-847. doi: 10.4155/bio-2017-0094. Epub 2017 Jun 19. No abstract available.

PMID: 28627228

 

A carbon dioxide stripping model for mammalian cell culture in manufacturing scale bioreactors.

Xing Z, Lewis AM, Borys MC, Li ZJ.

Biotechnol Bioeng. 2017 Jun;114(6):1184-1194. doi: 10.1002/bit.26232. Epub 2017 Feb 15.

PMID: 27922179

 

Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy.

Lopes RD, Guimarães PO, Kolls BJ, Wojdyla DM, Bushnell CD, Hanna M, Easton JD, Thomas L, Wallentin L, Al-Khatib SM, Held C, Gabriel Melo de Barros E Silva P, Alexander JH, Granger CB, Diener HC.

Blood. 2017 Jun 1;129(22):2980-2987. doi: 10.1182/blood-2016-08-731638. Epub 2017 Mar 29.

PMID: 28356246

 

A window of opportunity for abatacept in RA: is disease duration an independent predictor of low disease activity/remission in clinical practice?

Harrold LR, Litman HJ, Connolly SE, Kelly S, Hua W, Alemao E, Rosenblatt L, Rebello S, Kremer JM.

Clin Rheumatol. 2017 Jun;36(6):1215-1220. doi: 10.1007/s10067-017-3588-7. Epub 2017 Mar 1.

PMID: 28251392

 

Systemic Treatment Patterns With Advanced or Recurrent Non-small Cell Lung Cancer in Japan: A Retrospective Hospital Administrative Database Study.

Wang F, Mishina S, Takai S, Le TK, Ochi K, Funato K, Matsuoka S, Ohe Y.

Clin Ther. 2017 Jun;39(6):1146-1160. doi: 10.1016/j.clinthera.2017.04.010. Epub 2017 May 18.

PMID: 28527959

 

Dapagliflozin in patients with type 1 diabetes: A post hoc analysis of the effect of insulin dose adjustments on 24-hour continuously monitored mean glucose and fasting β-hydroxybutyrate levels in a phase IIa pilot study.

Henry RR, Dandona P, Pettus J, Mudaliar S, Xu J, Hansen L.

Diabetes Obes Metab. 2017 Jun;19(6):814-821. doi: 10.1111/dom.12882. Epub 2017 Mar 27.

PMID: 28098426

 

Coproporphyrin-I: A Fluorescent, Endogenous Optimal Probe Substrate for ABCC2 (MRP2) Suitable for Vesicle-Based MRP2 Inhibition Assay.

Gilibili RR, Chatterjee S, Bagul P, Mosure KW, Murali BV, Mariappan TT, Mandlekar S, Lai Y.

Drug Metab Dispos. 2017 Jun;45(6):604-611. doi: 10.1124/dmd.116.074740. Epub 2017 Mar 21.

PMID: 28325716

 

Metabolite Identification, Reaction Phenotyping, and Retrospective Drug-Drug Interaction Predictions of 17-Deacetylnorgestimate, the Active Component of the Oral Contraceptive Norgestimate.

Ahire D, Sinha S, Brock B, Iyer R, Mandlekar S, Subramanian M.

Drug Metab Dispos. 2017 Jun;45(6):676-685. doi: 10.1124/dmd.116.073940. Epub 2017 Mar 10.

PMID: 28283499

 

Safety, pharmacokinetics, and pharmacodynamics of BMS-986142, a novel reversible BTK inhibitor, in healthy participants.

Lee SK, Xing J, Catlett IM, Adamczyk R, Griffies A, Liu A, Murthy B, Nowak M.

Eur J Clin Pharmacol. 2017 Jun;73(6):689-698. doi: 10.1007/s00228-017-2226-2. Epub 2017 Mar 6.

PMID: 28265691

New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

Cowie MR, Filippatos GS, Alonso Garcia MLA, Anker SD, Baczynska A, Bloomfield DM, Borentain M, Bruins Slot K, Cronin M, Doevendans PA, El-Gazayerly A, Gimpelewicz C, Honarpour N, Janmohamed S, Janssen H, Kim AM, Lautsch D, Laws I, Lefkowitz M, Lopez-Sendon J, Lyon AR, Malik FI, McMurray JJV, Metra M, Figueroa Perez S, Pfeffer MA, Pocock SJ, Ponikowski P, Prasad K, Richard-Lordereau I, Roessig L, Rosano GMC, Sherman W, Stough WG, Swedberg K, Tyl B, Zannad F, Boulton C, De Graeff P.

Eur J Heart Fail. 2017 Jun;19(6):718-727. doi: 10.1002/ejhf.809. Epub 2017 Mar 27. Review.

PMID: 28345190

 

Dasatinib versus imatinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia: a subanalysis of the DASISION 5-year final report.

Nakamae H, Fujisawa S, Ogura M, Uchida T, Onishi Y, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Ohashi K, Li L, Miyoshi M.

Int J Hematol. 2017 Jun;105(6):792-804. doi: 10.1007/s12185-017-2208-2. Epub 2017 Mar 24.

PMID: 28341918

 

Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC.

Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Ríos J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM.

J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.

PMID: 28131794

 

Synthesis of neutral ether lipid monoalkyl-diacylglycerol by lipid acyltransferases.

Ma Z, Onorato JM, Chen L, Nelson DW, Yen CE, Cheng D.

J Lipid Res. 2017 Jun;58(6):1091-1099. doi: 10.1194/jlr.M073445. Epub 2017 Apr 18.

PMID: 28420705

 

Warfarin Management and Outcomes in Patients with Nonvalvular Atrial Fibrillation Within an Integrated Health Care System.

An J, Niu F, Zheng C, Rashid N, Mendes RA, Dills D, Vo L, Singh P, Bruno A, Lang DT, Le PT, Jazdzewski KP, Aranda G Jr.

J Manag Care Spec Pharm. 2017 Jun;23(6):700-712. doi: 10.18553/jmcp.2017.23.6.700.

PMID: 28530526

 

A High-Throughput Bioluminescent Assay to Monitor the Deamidation of Asparagine and Isomerization of Aspartate Residues in Therapeutic Proteins and Antibodies.

Hsiao K, Alves J, Patel R, Adams M, Nashine V, Goueli S.

J Pharm Sci. 2017 Jun;106(6):1528-1537. doi: 10.1016/j.xphs.2017.02.022. Epub 2017 Mar 2.

PMID: 28263844

 

Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study).

Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M.

Liver Int. 2017 Jun;37(6):836-842. doi: 10.1111/liv.13335. Epub 2017 Feb 2.

PMID: 27943563

 

Metabolomic profiling distinction of human nonalcoholic fatty liver disease progression from a common rat model.

Han J, Dzierlenga AL, Lu Z, Billheimer DD, Torabzadeh E, Lake AD, Li H, Novak P, Shipkova P, Aranibar N, Robertson D, Reily MD, Lehman-McKeeman LD, Cherrington NJ.

Obesity (Silver Spring). 2017 Jun;25(6):1069-1076. doi: 10.1002/oby.21855. Epub 2017 Apr 28.

PMID: 28452429

 

Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis.

Larkin J, Chmielowski B, Lao CD, Hodi FS, Sharfman W, Weber J, Suijkerbuijk KPM, Azevedo S, Li H, Reshef D, Avila A, Reardon DA.

Oncologist. 2017 Jun;22(6):709-718. doi: 10.1634/theoncologist.2016-0487. Epub 2017 May 11.

PMID: 28495807

 

Improvements in Fatigue in 1536 Patients with Rheumatoid Arthritis and Correlation with Other Treatment Outcomes: A Post Hoc Analysis of Three Randomized Controlled Trials of Abatacept.

Gossec L, Ahdjoudj S, Alemao E, Strand V.

Rheumatol Ther. 2017 Jun;4(1):99-109. doi: 10.1007/s40744-017-0054-6. Epub 2017 Mar 1.

PMID: 28251584

 

Ischemic Stroke in Nonvalvular Atrial Fibrillation at Warfarin Initiation: Assessment via a Large Insurance Database.

Tepper PG, Liu X, Hamilton M, Mardekian J, Petkun W, Tan W, Singer DE.

Stroke. 2017 Jun;48(6):1487-1494. doi: 10.1161/STROKEAHA.116.015535. Epub 2017 Apr 26.

PMID: 28446621

 

Comprehensive evaluation of liver microsomal cytochrome P450 3A (CYP3A) inhibition: comparison of cynomolgus monkey and human.

Haarhoff ZE, Kramer MA, Zvyaga TA, Zhang J, Bhutani P, Subramanian M, Rodrigues AD.

Xenobiotica. 2017 Jun;47(6):470-478. doi: 10.1080/00498254.2016.1203042. Epub 2016 Aug 8.

PMID: 27498589

 

Perspectives on Subcutaneous Route of Administration as an Immunogenicity Risk Factor for Therapeutic Proteins.

Hamuro L, Kijanka G, Kinderman F, Kropshofer H, Bu DX, Zepeda M, Jawa V.

J Pharm Sci. 2017 May 31. pii: S0022-3549(17)30422-7. doi: 10.1016/j.xphs.2017.05.030. [Epub ahead of print] Review.

PMID: 28576695

 

IL-17 induced NOTCH1 activation in oligodendrocyte progenitor cells enhances proliferation and inflammatory gene expression.

Wang C, Zhang CJ, Martin BN, Bulek K, Kang Z, Zhao J, Bian G, Carman JA, Gao J, Dongre A, Xue H, Miller SD, Qian Y, Hambardzumyan D, Hamilton T, Ransohoff RM, Li X.

Nat Commun. 2017 May 31;8:15508. doi: 10.1038/ncomms15508.

PMID: 28561022

 

Radiation-agent combinations for glioblastoma: challenges in drug development and future considerations.

Kunos CA, Galanis E, Buchsbaum J, Shi Q, Strauss LC, Coleman CN, Ahmed MM.

J Neurooncol. 2017 May 30. doi: 10.1007/s11060-017-2458-0. [Epub ahead of print] Review.

PMID: 28560665

 

Identification of leachables observed in the size exclusion chromatograms of a low concentration product stored in prefilled syringes.

Valente JJ, Peddicord MB, Rinaldi FA, Kelly KA, Bolgar MS.

J Pharm Biomed Anal. 2017 May 30;139:133-142. doi: 10.1016/j.jpba.2017.02.039. Epub 2017 Feb 22.

PMID: 28279928

 

Evaluation of automated Wes system as an analytical and characterization tool to support monoclonal antibody drug product development.

Wang J, Valdez A, Chen Y.

J Pharm Biomed Anal. 2017 May 30;139:263-268. doi: 10.1016/j.jpba.2016.12.024. Epub 2016 Dec 21.

PMID: 28069351

 

Peg-Interferon Lambda Treatment Induces Robust Innate and Adaptive Immunity in Chronic Hepatitis B Patients.

Phillips S, Mistry S, Riva A, Cooksley H, Hadzhiolova-Lebeau T, Plavova S, Katzarov K, Simonova M, Zeuzem S, Woffendin C, Chen PJ, Peng CY, Chang TT, Lueth S, De Knegt R, Choi MS, Wedemeyer H, Dao M, Kim CW, Chu HC, Wind-Rotolo M, Williams R, Cooney E, Chokshi S.

Front Immunol. 2017 May 29;8:621. doi: 10.3389/fimmu.2017.00621. eCollection 2017.

PMID: 28611778

 

Molecular properties associated with transporter-mediated drug disposition.

Varma MV, Lai Y, El-Kattan AF.

Adv Drug Deliv Rev. 2017 May 26. pii: S0169-409X(17)30070-4. doi: 10.1016/j.addr.2017.05.014. [Epub ahead of print]

PMID: 28554577

 

Discovery of a Hepatitis C Virus NS5B Replicase Palm Site Allosteric Inhibitor (BMS-929075) Advanced to Phase 1 Clinical Studies.

Yeung KS, Beno BR, Parcella K, Bender JA, Grant-Young KA, Nickel A, Gunaga P, Anjanappa P, Bora RO, Selvakumar K, Rigat K, Wang YK, Liu M, Lemm J, Mosure K, Sheriff S, Wan C, Witmer M, Kish K, Hanumegowda U, Zhuo X, Shu YZ, Parker D, Haskell R, Ng A, Gao Q, Colston E, Raybon J, Grasela DM, Santone K, Gao M, Meanwell NA, Sinz M, Soars MG, Knipe JO, Roberts SB, Kadow JF.

J Med Chem. 2017 May 25;60(10):4369-4385. doi: 10.1021/acs.jmedchem.7b00328. Epub 2017 May 4.

PMID: 28430437

 

Structural basis for cancer immunotherapy by the first-in-class checkpoint inhibitor ipilimumab.

Ramagopal UA, Liu W, Garrett-Thomson SC, Bonanno JB, Yan Q, Srinivasan M, Wong SC, Bell A, Mankikar S, Rangan VS, Deshpande S, Korman AJ, Almo SC.

Proc Natl Acad Sci U S A. 2017 May 23;114(21):E4223-E4232. doi: 10.1073/pnas.1617941114. Epub 2017 May 8.

PMID: 28484017

 

High hepatitis C viral load and genotype 2 are strong predictors of chronic kidney disease.

Lai TS, Lee MH, Yang HI, You SL, Lu SN, Wang LY, Yuan Y, L'Italien G, Chien KL, Chen CJ; REVEAL-HCV Study Group.

Kidney Int. 2017 May 20. pii: S0085-2538(17)30216-8. doi: 10.1016/j.kint.2017.03.021. [Epub ahead of print]

PMID: 28532708

 

Suboptimal Anticoagulant Management in Japanese Patients with Nonvalvular Atrial Fibrillation Receiving Warfarin for Stroke Prevention.

Hirano T, Kaneko H, Mishina S, Wang F, Morita S.

J Stroke Cerebrovasc Dis. 2017 May 19. pii: S1052-3057(17)30204-5. doi: 10.1016/j.jstrokecerebrovasdis.2017.04.030. [Epub ahead of print]

PMID: 28532651

 

Effect of Apixaban on All-Cause Death in Patients with Atrial Fibrillation: a Meta-Analysis Based on Imputed Placebo Effect.

Guimarães PO, Lopes RD, Wojdyla DM, Abdul-Rahim AH, Connolly SJ, Flaker GC, Wang J, Hanna M, Granger CB, Wallentin L, Lees KR, Alexander JH, McMurray JJV.

Cardiovasc Drugs Ther. 2017 May 18. doi: 10.1007/s10557-017-6728-z. [Epub ahead of print]

PMID: 28516318

 

An integrated epidemiological and neural net model of the warfarin effect in managed care patients.

Jacobs DM, Stefanovic F, Wilton G, Gomez-Caminero A, Schentag JJ.

Clin Pharmacol. 2017 May 18;9:55-64. doi: 10.2147/CPAA.S136243. eCollection 2017.

PMID: 28572740

 

Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors.

Zhao X, Suryawanshi S, Hruska M, Feng Y, Wang X, Shen J, Vezina HE, McHenry MB, Waxman IM, Achanta A, Bello A, Roy A, Agrawal S.

Ann Oncol. 2017 May 17. doi: 10.1093/annonc/mdx235. [Epub ahead of print]

PMID: 28520840

 

The Utility of a Population Approach in Drug-Drug Interaction Assessments: A Simulation Evaluation.

Wang DD, Yu Y, Kassir N, Zhu M, Hanley WD, Earp JC, Chow AT, Gupta M, Hu C.

J Clin Pharmacol. 2017 May 17. doi: 10.1002/jcph.921. [Epub ahead of print]

PMID: 28513856

 

Host Cell Protein Profiling by Targeted and Untargeted Analysis of Data Independent Acquisition Mass Spectrometry Data with Parallel Reaction Monitoring Verification.

Kreimer S, Gao Y, Ray S, Jin M, Tan Z, Mussa NA, Tao L, Li Z, Ivanov AR, Karger BL.

Anal Chem. 2017 May 16;89(10):5294-5302. doi: 10.1021/acs.analchem.6b04892. Epub 2017 Apr 26.

PMID: 28402653

 

Interferon-λ Mediates Non-redundant Front-Line Antiviral Protection against Influenza Virus Infection without Compromising Host Fitness.

Galani IE, Triantafyllia V, Eleminiadou EE, Koltsida O, Stavropoulos A, Manioudaki M, Thanos D, Doyle SE, Kotenko SV, Thanopoulou K, Andreakos E.

Immunity. 2017 May 16;46(5):875-890.e6. doi: 10.1016/j.immuni.2017.04.025.

PMID: 28514692

 

A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials.

Young TC, Srinivasan S, Vetter ML, Sethuraman V, Bhagwagar Z, Zwirtes R, Narasimhan P, Chuang T, Smyth BJ.

J Clin Pharmacol. 2017 May 16. doi: 10.1002/jcph.913. [Epub ahead of print]

PMID: 28510323

 

[₃H]BMT-046091 a potent and selective radioligand to determine AAK1 distribution and target engagement.

Louis JV, Lu Y, Pieschl R, Tian Y, Hong Y, Dandapani K, Naidu S, Vikramadithyan RK, Dzierba C, Sarvasiddhi SK, Nara SJ, Bronson J, Macor JE, Albright C, Kostich W, Li YW.

Neuropharmacology. 2017 May 15;118:167-174. doi: 10.1016/j.neuropharm.2017.03.015. Epub 2017 Mar 15.

PMID: 28315351

 

Belatacept Resistant Rejection is Associated with CD28₊ Memory CD8 T cells.

Mathews DV, Wakwe WC, Kim SC, Lowe MC, Breeden C, Roberts ME, Farris AB, Strobert EA, Jenkins JB, Larsen CP, Ford ML, Townsend R, Adams AB.

Am J Transplant. 2017 May 14. doi: 10.1111/ajt.14349. [Epub ahead of print]

PMID: 28502128

 

Modulation of K_v 11.1 (hERG) channels by 5-(((1H-indazol-5-yl)oxy)methyl)-N-(4-(trifluoromethoxy)phenyl)pyrimidin-2-amine (ITP-2), a novel small molecule activator.

Sale H, Roy S, Warrier J, Thangathirupathy S, Vadari Y, Gopal SK, Krishnamurthy P, Ramarao M.

Br J Pharmacol. 2017 May 12. doi: 10.1111/bph.13859. [Epub ahead of print]

PMID: 28500657

 

Selective I_Kur Inhibitors for the Potential Treatment of Atrial Fibrillation: Optimization of the Phenyl Quinazoline Series Leading to Clinical Candidate 5-[5-Phenyl-4-(pyridin-2-ylmethylamino)quinazolin-2-yl]pyridine-3-sulfonamide.

Gunaga P, Lloyd J, Mummadi S, Banerjee A, Dhondi NK, Hennan J, Subray V, Jayaram R, Rajugowda N, Umamaheshwar Reddy K, Kumaraguru D, Mandal U, Beldona D, Adisechen AK, Yadav N, Warrier J, Johnson JA, Sale H, Putlur SP, Saxena A, Chimalakonda A, Mandlekar S, Conder M, Xing D, Gupta AK, Gupta A, Rampulla R, Mathur A, Levesque P, Wexler RR, Finlay HJ.

J Med Chem. 2017 May 11;60(9):3795-3803. doi: 10.1021/acs.jmedchem.6b01889. Epub 2017 Apr 28.

PMID: 28418664

 

Decarboxylative alkenylation.

Edwards JT, Merchant RR, McClymont KS, Knouse KW, Qin T, Malins LR, Vokits B, Shaw SA, Bao DH, Wei FL, Zhou T, Eastgate MD, Baran PS.

Nature. 2017 May 11;545(7653):213-218. doi: 10.1038/nature22307. Epub 2017 Apr 19.

PMID: 28424520

 

Focused microwave irradiation-assisted immunohistochemistry to study effects of ketamine on phospho-ERK expression in the mouse brain.

Fernandes A, Li YW.

Brain Res. 2017 May 10. pii: S0006-8993(17)30204-4. doi: 10.1016/j.brainres.2017.05.008. [Epub ahead of print]

PMID: 28501494

 

Tiered analytics for purity assessment of macrocyclic peptides in drug discovery: Analytical consideration and method development.

Qian Cutrone JJ, Huang XS, Kozlowski ES, Bao Y, Wang Y, Poronsky CS, Drexler DM, Tymiak AA.

J Pharm Biomed Anal. 2017 May 10;138:166-174. doi: 10.1016/j.jpba.2017.01.056. Epub 2017 Feb 3.

PMID: 28213177

 

Rate-Dependent Role of I_Kur in Human Atrial Repolarization and Atrial Fibrillation Maintenance.

Aguilar M, Feng J, Vigmond E, Comtois P, Nattel S.

Biophys J. 2017 May 9;112(9):1997-2010. doi: 10.1016/j.bpj.2017.03.022.

PMID: 28494969

 

4-Cyanobenzenesulfonamides: Amine Synthesis and Protecting Strategy To Compliment the Nosyl Group.

Schmidt MA, Stokes RW, Davies ML, Roberts F.

J Org Chem. 2017 May 5;82(9):4550-4560. doi: 10.1021/acs.joc.7b00608. Epub 2017 Apr 19.

PMID: 28410437

 

Synthesis of HIV-Maturation Inhibitor BMS-955176 from Betulin by an Enabling Oxidation Strategy.

Ortiz A, Soumeillant M, Savage SA, Strotman NA, Haley M, Benkovics T, Nye J, Xu Z, Tan Y, Ayers S, Gao Q, Kiau S.

J Org Chem. 2017 May 5;82(9):4958-4963. doi: 10.1021/acs.joc.7b00438. Epub 2017 Apr 19.

PMID: 28406018

 

A Nondestructive Method for Measuring Protein Distribution in Frozen Drug Substance.

Du C, Borwankar A, Singh N, Borys M, Li ZJ.

J Pharm Sci. 2017 May 5. pii: S0022-3549(17)30316-7. doi: 10.1016/j.xphs.2017.04.047. [Epub ahead of print]

PMID: 28483421

 

Duplicated Enhancer Region Increases Expression of CTSB and Segregates with Keratolytic Winter Erythema in South African and Norwegian Families.

Ngcungcu T, Oti M, Sitek JC, Haukanes BI, Linghu B, Bruccoleri R, Stokowy T, Oakeley EJ, Yang F, Zhu J, Sultan M, Schalkwijk J, van Vlijmen-Willems IMJJ, von der Lippe C, Brunner HG, Ersland KM, Grayson W, Buechmann-Moller S, Sundnes O, Nirmala N, Morgan TM, van Bokhoven H, Steen VM, Hull PR, Szustakowski J, Staedtler F, Zhou H, Fiskerstrand T, Ramsay M.

Am J Hum Genet. 2017 May 4;100(5):737-750. doi: 10.1016/j.ajhg.2017.03.012. Epub 2017 Apr 27.

PMID: 28457472

 

Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis.

Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD.

Ann Rheum Dis. 2017 May 4. pii: annrheumdis-2016-210724. doi: 10.1136/annrheumdis-2016-210724. [Epub ahead of print]

PMID: 28473423

 

Strategy for the Quantitation of a Protein Conjugate via Hybrid Immunocapture-Liquid Chromatography with Sequential HRMS and SRM-Based LC-MS/MS Analyses.

Zhao Y, Liu G, Yuan X, Gan J, Peterson JE, Shen JX.

Anal Chem. 2017 May 2;89(9):5144-5151. doi: 10.1021/acs.analchem.7b00926. Epub 2017 Apr 21.

PMID: 28402627

 

Antibody Drug-Target Engagement Measurement in Tissue Using Quantitative Affinity Extraction Liquid Chromatography-Mass Spectrometry: Method Development and Qualification.

Ciccimaro E, Zhu Y, Ostanin D, Suchard S, MacGuire J, Xiao Q, Dongre A, Chimalakonda A, Olah T, Shipkova P.

Anal Chem. 2017 May 2;89(9):5115-5123. doi: 10.1021/acs.analchem.7b00688. Epub 2017 Apr 21.

PMID: 28383906

 

Ultrafiltration behavior of monoclonal antibodies and Fc-fusion proteins: Effects of physical properties.

Baek Y, Singh N, Arunkumar A, Borys M, Li ZJ, Zydney AL.

Biotechnol Bioeng. 2017 May 2. doi: 10.1002/bit.26326. [Epub ahead of print]

PMID: 28464237

 

Translational pharmacokinetic-pharmacodynamic analysis in the pharmaceutical industry: an IQ Consortium PK-PD Discussion Group perspective.

Wong H, Bohnert T, Damian-Iordache V, Gibson C, Hsu CP, Krishnatry AS, Liederer BM, Lin J, Lu Q, Mettetal JT, Mudra DR, Nijsen MJMA, Schroeder P, Schuck E, Suryawanshi S, Trapa P, Tsai A, Wang H, Wu F.

Drug Discov Today. 2017 May 2. pii: S1359-6446(17)30002-8. doi: 10.1016/j.drudis.2017.04.015. [Epub ahead of print]

PMID: 28476536

 

Exploring Canine-Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs.

Martinez MN, Mistry B, Lukacova V, Lentz KA, Polli JE, Hoag SW, Dowling T, Kona R, Fahmy RM.

AAPS J. 2017 May;19(3):712-726. doi: 10.1208/s12248-017-0055-y. Epub 2017 Mar 6.

PMID: 28265981

 

Erratum to: Reliable Rate Measurements for Active and Passive Hepatic Uptake Using Plated Human Hepatocytes.

Bi YA, Scialis RJ, Lazzaro S, Mathialagan S, Kimoto E, Keefer J, Zhang H, Vildhede AM, Costales C, Rodrigues AD, Tremaine LM, Varma MVS.

AAPS J. 2017 May;19(3):882. doi: 10.1208/s12248-017-0061-0. No abstract available.

PMID: 28233243

 

Reliable Rate Measurements for Active and Passive Hepatic Uptake Using Plated Human Hepatocytes.

Bi YA, Scialis RJ, Lazzaro S, Mathialagan S, Kimoto E, Keefer J, Zhang H, Vildhede AM, Costales C, Rodrigues AD, Tremaine LM, Varma MVS.

AAPS J. 2017 May;19(3):787-796. doi: 10.1208/s12248-017-0051-2. Epub 2017 Feb 10. Erratum in: AAPS J. 2017 May;19(3):882.

PMID: 28188574

 

Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium.

Piccini JP, Clark RL, Kowey PR, Mittal S, Dunnmon P, Stockbridge N, Reiffel JA, Turakhia MP, Ziegler PD, Kleiman RB, Ismat F, Sager P.

Am Heart J. 2017 May;187:156-169. doi: 10.1016/j.ahj.2017.01.012. Epub 2017 Jan 26. Review.

PMID: 28454799

 

A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma.

Berenson J, Manges R, Badarinath S, Cartmell A, McIntyre K, Lyons R, Harb W, Mohamed H, Nourbakhsh A, Rifkin R.

Am J Hematol. 2017 May;92(5):460-466. doi: 10.1002/ajh.24687. Epub 2017 Mar 22.

PMID: 28213943

 

Safety and Efficacy Outcomes 3 Years After Switching to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: Results From a Phase 2 Randomized Trial.

Grinyó JM, Del Carmen Rial M, Alberu J, Steinberg SM, Manfro RC, Nainan G, Vincenti F, Jones-Burton C, Kamar N.

Am J Kidney Dis. 2017 May;69(5):587-594. doi: 10.1053/j.ajkd.2016.09.021. Epub 2016 Nov 23.

PMID: 27889299

 

Fc-Silent Anti-CD154 Domain Antibody Effectively Prevents Nonhuman Primate Renal Allograft Rejection.

Kim SC, Wakwe W, Higginbotham LB, Mathews DV, Breeden CP, Stephenson AC, Jenkins J, Strobert E, Price K, Price L, Kuhn R, Wang H, Yamniuk A, Suchard S, Farris AB 3rd, Pearson TC, Larsen CP, Ford ML, Suri A, Nadler S, Adams AB.

Am J Transplant. 2017 May;17(5):1182-1192. doi: 10.1111/ajt.14197. Epub 2017 Feb 25.

PMID: 28097811

 

Apixaban Versus Warfarin for Mechanical Heart Valve Thromboprophylaxis in a Swine Aortic Heterotopic Valve Model.

Lester PA, Coleman DM, Diaz JA, Jackson TO, Hawley AE, Mathues AR, Grant BT, Knabb RM, Ramacciotti E, Frost CE, Song Y, Wakefield TW, Myers DD Jr.

Arterioscler Thromb Vasc Biol. 2017 May;37(5):942-948. doi: 10.1161/ATVBAHA.116.308649. Epub 2017 Feb 23.

PMID: 28232327

 

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non-Small-Cell Lung Cancer (RTOG 3505).

Gerber DE, Urbanic JJ, Langer C, Hu C, Chang IF, Lu B, Movsas B, Jeraj R, Curran WJ, Bradley JD.

Clin Lung Cancer. 2017 May;18(3):333-339. doi: 10.1016/j.cllc.2016.10.009. Epub 2016 Oct 26.

PMID: 27923550

 

Population Pharmacokinetics, Pharmacodynamics, and Exploratory Exposure-Response Analyses of Apixaban in Subjects Treated for Venous Thromboembolism.

Byon W, Sweeney K, Frost C, Boyd RA.

CPT Pharmacometrics Syst Pharmacol. 2017 May;6(5):340-349. doi: 10.1002/psp4.12184.

PMID: 28547774

 

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects.

Theunissen PT, Beken S, Beyer B, Breslin WJ, Cappon GD, Chen CL, Chmielewski G, de Schaepdrijver L, Enright B, Foreman JE, Harrouk W, Hew KW, Hoberman AM, Y Hui J, Knudsen TB, Laffan SB, Makris SL, Martin M, McNerney ME, Siezen CL, Stanislaus DJ, Stewart J, Thompson KE, Tornesi B, Van der Laan JW, Weinbauer GF, Wood S, Piersma AH.

Crit Rev Toxicol. 2017 May;47(5):402-414. doi: 10.1080/10408444.2016.1224808. Epub 2016 Oct 21.

PMID: 27766926

 

Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype.

Goolsby Hunter A, Rosenblatt L, Patel C, Blauer-Peterson C, Anduze-Faris B.

Curr Med Res Opin. 2017 May;33(5):829-836. doi: 10.1080/03007995.2017.1288613. Epub 2017 Feb 10.

PMID: 28128648

 

A survey on IVIVC/IVIVR development in the pharmaceutical industry - Past experience and current perspectives.

Nguyen MA, Flanagan T, Brewster M, Kesisoglou F, Beato S, Biewenga J, Crison J, Holm R, Li R, Mannaert E, McAllister M, Mueller-Zsigmondy M, Muenster U, Ojala K, Page S, Parr A, Rossenu S, Timmins P, Van Peer A, Vermeulen A, Langguth P.

Eur J Pharm Sci. 2017 May 1;102:1-13. doi: 10.1016/j.ejps.2017.02.029. Epub 2017 Feb 21. Review.

PMID: 28235611

 

The Second-Generation Maturation Inhibitor GSK3532795 Maintains Potent Activity Toward HIV Protease Inhibitor-Resistant Clinical Isolates.

Ray N, Li T, Lin Z, Protack T, van Ham PM, Hwang C, Krystal M, Nijhuis M, Lataillade M, Dicker I.

J Acquir Immune Defic Syndr. 2017 May 1;75(1):52-60. doi: 10.1097/QAI.0000000000001304.

PMID: 28234686

 

Management of skin adverse events associated with immune checkpoint inhibitors in patients with melanoma: A nursing perspective.

Thebeau M, Rubin K, Hofmann M, Grimm J, Weinstein A, Choi JN.

J Am Assoc Nurse Pract. 2017 May;29(5):294-303. doi: 10.1002/2327-6924.12458. Epub 2017 Apr 24.

PMID: 28436601

 

Editorial and Review: 28th ASMS Sanibel Conference on Mass Spectrometry-Characterization of Protein Therapeutics by Mass Spectrometry.

Sperry JB, Chen G, Loo JA.

J Am Soc Mass Spectrom. 2017 May;28(5):781-785. doi: 10.1007/s13361-017-1629-8. No abstract available.

PMID: 28374311

 

Characterization of Aggregation Propensity of a Human Fc-Fusion Protein Therapeutic by Hydrogen/Deuterium Exchange Mass Spectrometry.

Huang RY, Iacob RE, Krystek SR, Jin M, Wei H, Tao L, Das TK, Tymiak AA, Engen JR, Chen G.

J Am Soc Mass Spectrom. 2017 May;28(5):795-802. doi: 10.1007/s13361-016-1452-7. Epub 2016 Aug 15.

PMID: 27527097

 

Prime-Boost Immunization Eliminates Metastatic Colorectal Cancer by Producing High-Avidity Effector CD8₊ T Cells.

Xiang B, Baybutt TR, Berman-Booty L, Magee MS, Waldman SA, Alexeev VY, Snook AE.

J Immunol. 2017 May 1;198(9):3507-3514. doi: 10.4049/jimmunol.1502672. Epub 2017 Mar 24.

PMID: 28341670

 

Advancement in bioprocess technology: parallels between microbial natural products and cell culture biologics.

Bandyopadhyay AA, Khetan A, Malmberg LH, Zhou W, Hu WS.

J Ind Microbiol Biotechnol. 2017 May;44(4-5):785-797. doi: 10.1007/s10295-017-1913-4. Epub 2017 Feb 9. Review.

PMID: 28185098

 

Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.

Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbé C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M.

Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.

PMID: 28359784

 

The renal elimination of apixaban: the totality of data relating to the renal clearance of apixaban in patients with impaired renal function: response to Hellfritzsch et al.

Byon W, Cirincione B, Di Russo G, LaCreta F, Boyd R.

Pharmacoepidemiol Drug Saf. 2017 May;26(5):603-605. doi: 10.1002/pds.4163. No abstract available.

PMID: 28444852

 

Comparison of cardiovascular risk algorithms in patients with vs without rheumatoid arthritis and the role of C-reactive protein in predicting cardiovascular outcomes in rheumatoid arthritis.

Alemao E, Cawston H, Bourhis F, Al M, Rutten-van Molken M, Liao KP, Solomon DH.

Rheumatology (Oxford). 2017 May 1;56(5):777-786. doi: 10.1093/rheumatology/kew440.

PMID: 28087832

 

The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.

Hauben M, Hung E, Wood J, Soitkar A, Reshef D.

Ther Adv Drug Saf. 2017 May;8(5):145-156. doi: 10.1177/2042098616685010. Epub 2017 Feb 1.

PMID: 28588760

 

Assessing the Budget Impact and Economic Outcomes of the Introduction of Daclatasvir + Asunaprevir and Sofosbuvir/Ledipasvir for the Treatment of Chronic Hepatitis C Virus Infection in Japan.

Ward T, Webster S, Mishina S, McEwan P, Wygant G, Wang F.

Value Health Reg Issues. 2017 May;12:1-6. doi: 10.1016/j.vhri.2016.10.002. Epub 2016 Dec 24.

PMID: 28648305

 

Deficiency of CCN5/WISP-2-Driven Program in breast cancer Promotes Cancer Epithelial cells to mesenchymal stem cells and Breast Cancer growth.

Das A, Dhar K, Maity G, Sarkar S, Ghosh A, Haque I, Dhar G, Banerjee S, Banerjee SK.

Sci Rep. 2017 Apr 27;7(1):1220. doi: 10.1038/s41598-017-00916-z.

PMID: 28450698

 

Assessing treatment efficacy in the subset of responders in a randomized clinical trial.

Korn EL, Othus M, Chen T, Freidlin B.

Ann Oncol. 2017 Apr 21. doi: 10.1093/annonc/mdx197. [Epub ahead of print]

PMID: 28444115

 

Revisiting a Classic Transformation: A Lossen Rearrangement Initiated by Nitriles and "Pseudo-Catalytic" in Isocyanate.

Strotman NA, Ortiz A, Savage SA, Wilbert CR, Ayers S, Kiau S.

J Org Chem. 2017 Apr 21;82(8):4044-4049. doi: 10.1021/acs.joc.7b00450. Epub 2017 Apr 12.

PMID: 28394130

 

The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications.

Anderson KC, Auclair D, Kelloff GJ, Sigman CC, Avet-Loiseau H, Farrell AT, Gormley NJ, Kumar SK, Landgren O, Munshi NC, Cavo M, Davies FE, Di Bacco A, Dickey JS, Gutman SI, Higley HR, Hussein MA, Jessup JM, Kirsch IR, Little RF, Loberg RD, Lohr JG, Mukundan L, Omel JL, Pugh TJ, Reaman GH, Robbins MD, Sasser AK, Valente N, Zamagni E.

Clin Cancer Res. 2017 Apr 20. pii: clincanres.2895.2016. doi: 10.1158/1078-0432.CCR-16-2895. [Epub ahead of print]

PMID: 28428191

 

Clinical Trial of the Anti-PD-L1 Antibody BMS-936559 in HIV-1 Infected Participants on Suppressive Antiretroviral Therapy.

Gay CL, Bosch RJ, Ritz J, Hataye JM, Aga E, Tressler RL, Mason SW, Hwang CK, Grasela DM, Ray N, Cyktor JC, Coffin JM, Acosta EP, Koup RA, Mellors JW, Eron JJ; AIDS Clinical Trials 5326 Study Team.

J Infect Dis. 2017 Apr 18. doi: 10.1093/infdis/jix191. [Epub ahead of print]

PMID: 28431010

 

Results from an Integrated Safety Analysis of Urelumab, an Agonist Anti-CD137 Monoclonal Antibody.

Segal NH, Logan TF, Hodi FS, McDermott D, Melero I, Hamid O, Schmidt H, Robert C, Chiarion-Sileni V, Ascierto PA, Maio M, Urba WJ, Gangadhar TC, Suryawanshi S, Neely J, Jure-Kunkel M, Krishnan S, Kohrt H, Sznol M, Levy R.

Clin Cancer Res. 2017 Apr 15;23(8):1929-1936. doi: 10.1158/1078-0432.CCR-16-1272. Epub 2016 Oct 18.

PMID: 27756788

 

Adenoma Prevalence in Blacks and Whites Having Equal Adherence To Screening Colonoscopy: The National Colonoscopy Study.

Mendelsohn RB, Winawer SJ, Jammula A, Mills G, Jordan P, O'Brien MJ, Close GM, Dorfman M, Church TR, Mandelson MT, Allen J, Feld A, Kauff ND, Morgan GA, Kumar JMR, Serrano V, Bayuga-Miller S, Fischer SE, Kuk D, Zauber AG.

Clin Gastroenterol Hepatol. 2017 Apr 15. pii: S1542-3565(17)30457-3. doi: 10.1016/j.cgh.2017.04.014. [Epub ahead of print] No abstract available.

PMID: 28419856

 

Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study.

Tomita Y, Fukasawa S, Shinohara N, Kitamura H, Oya M, Eto M, Tanabe K, Kimura G, Yonese J, Yao M, Motzer RJ, Uemura H, McHenry MB, Berghorn E, Ozono S.

Jpn J Clin Oncol. 2017 Apr 13:1-8. doi: 10.1093/jjco/hyx049. [Epub ahead of print]

PMID: 28419248

 

Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.

Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S.

Eur Urol. 2017 Apr 12. pii: S0302-2838(17)30265-8. doi: 10.1016/j.eururo.2017.03.037. [Epub ahead of print]

PMID: 28410865

 

Comparative study of therapeutic antibody candidates derived from mini-pool and clonal cell lines.

Fan L, Rizzi G, Bierilo K, Tian J, Yee JC, Russell R, Das TK.

Biotechnol Prog. 2017 Apr 10. doi: 10.1002/btpr.2477. [Epub ahead of print]

PMID: 28393481

 

Asymmetric Synthesis of the Major Metabolite of a Calcitonin Gene-Related Peptide Receptor Antagonist and Mechanism of Epoxide Hydrogenolysis.

Luo G, Chen L, Conway CM, Kostich W, Johnson BM, Ng A, Macor JE, Dubowchik GM.

J Org Chem. 2017 Apr 7;82(7):3710-3720. doi: 10.1021/acs.joc.7b00052. Epub 2017 Mar 28.

PMID: 28306261

 

Transcriptome Alterations in Prefrontal Pyramidal Cells Distinguish Schizophrenia From Bipolar and Major Depressive Disorders.

Arion D, Huo Z, Enwright JF, Corradi JP, Tseng G, Lewis DA.

Biol Psychiatry. 2017 Apr 4. pii: S0006-3223(17)31442-7. doi: 10.1016/j.biopsych.2017.03.018. [Epub ahead of print]

PMID:28476208

 

Hepatitis C Viral Load, Genotype, and Increased Risk of Developing End-stage Renal Disease: REVEAL-HCV Study.

Lai TS, Lee MH, Yang HI, You SL, Lu SN, Wang LY, Yuan Y, L'Italien G, Chien KL, Chen CJ; REVEAL-HCV Study Group.

Hepatology. 2017 Apr 2. doi: 10.1002/hep.29192. [Epub ahead of print]

PMID: 28370058

 

A Fluorescence-Based High-Throughput Coupled Enzymatic Assay for Quantitation of Isoaspartate in Proteins and Peptides.

Puri A, Quan Y, Narang AS, Adams M, Gandhi R, Nashine VC.

AAPS PharmSciTech. 2017 Apr;18(3):803-808. doi: 10.1208/s12249-016-0570-7. Epub 2016 Jun 24.

PMID: 27342117

 

Development, optimization and implementation of a centralized metabolic soft spot assay.

Paiva AA, Klakouski C, Li S, Johnson BM, Shu YZ, Josephs J, Zvyaga T, Zamora I, Shou WZ.

Bioanalysis. 2017 Apr;9(7):541-552. doi: 10.4155/bio-2016-0299. Epub 2017 Mar 24.

PMID: 28339283

 

In vitro and in vivo evaluation of dasatinib and imatinib on physiological parameters of pulmonary arterial hypertension.

Baumgart B, Guha M, Hennan J, Li J, Woicke J, Simic D, Graziano M, Wallis N, Sanderson T, Bunch RT.

Cancer Chemother Pharmacol. 2017 Apr;79(4):711-723. doi: 10.1007/s00280-017-3264-2. Epub 2017 Mar 10.

PMID: 28283735

 

Masterful Antibodies: Checkpoint Blockade.

Lonberg N, Korman AJ.

Cancer Immunol Res. 2017 Apr;5(4):275-281. doi: 10.1158/2326-6066.CIR-17-0057. Review.

PMID: 28373215

 

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations.

Butler J, Hamo CE, Udelson JE, O'Connor C, Sabbah HN, Metra M, Shah SJ, Kitzman DW, Teerlink JR, Bernstein HS, Brooks G, Depre C, DeSouza MM, Dinh W, Donovan M, Frische-Danielson R, Frost RJ, Garza D, Gohring UM, Hellawell J, Hsia J, Ishihara S, Kay-Mugford P, Koglin J, Kozinn M, Larson CJ, Mayo M, Gan LM, Mugnier P, Mushonga S, Roessig L, Russo C, Salsali A, Satler C, Shi V, Ticho B, van der Laan M, Yancy C, Stockbridge N, Gheorghiade M.

Circ Heart Fail. 2017 Apr;10(4). pii: e003800. doi: 10.1161/CIRCHEARTFAILURE.116.003800.

PMID: 28356300

 

Investigating Transporter-Mediated Drug-Drug Interactions Using a Physiologically Based Pharmacokinetic Model of Rosuvastatin.

Wang Q, Zheng M, Leil T.

CPT Pharmacometrics Syst Pharmacol. 2017 Apr;6(4):228-238. doi: 10.1002/psp4.12168. Epub 2017 Mar 13.

PMID: 28296193

 

The value of open access and a patient centric approach to oral oncolytic utilization in the treatment of Chronic Myelogenous Leukemia: A U.S. perspective.

Das L, Gitlin M, Siegartel LR, Makenbaeva D.

Expert Rev Pharmacoecon Outcomes Res. 2017 Apr;17(2):133-140. doi: 10.1080/14737167.2017.1305892. Epub 2017 Mar 22. Review.

PMID: 28287008

 

Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation.

Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB.

Heart. 2017 Apr;103(8):623-628. doi: 10.1136/heartjnl-2016-309901. Epub 2016 Oct 24.

PMID: 27798052

 

Effects of aripiprazole and haloperidol on neural activation during a simple motor task in healthy individuals: A functional MRI study.

Goozee R, O'Daly O, Handley R, Reis Marques T, Taylor H, McQueen G, Hubbard K, Pariante C, Mondelli V, Reinders AA, Dazzan P.

Hum Brain Mapp. 2017 Apr;38(4):1833-1845. doi: 10.1002/hbm.23485. Epub 2016 Dec 23.

PMID: 28009070

 

Role of Fc-FcγR interactions in the antitumor activity of therapeutic antibodies.

Barnhart BC, Quigley M.

Immunol Cell Biol. 2017 Apr;95(4):340-346. doi: 10.1038/icb.2016.121. Epub 2016 Dec 15. Review.

PMID: 27974746

 

A novel approach to measuring macrophage-specific reverse cholesterol transport in vivo in humans.

Cuchel M, Raper AC, Conlon DM, Pryma DA, Freifelder RH, Poria R, Cromley D, Li X, Dunbar RL, French B, Qu L, Farver W, Su CC, Lund-Katz S, Baer A, Ruotolo G, Akerblad P, Ryan CS, Xiao L, Kirchgessner TG, Millar JS, Billheimer JT, Rader DJ.

J Lipid Res. 2017 Apr;58(4):752-762. doi: 10.1194/jlr.M075226. Epub 2017 Feb 6.

PMID: 28167703

 

Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products.

Almaya A, De Belder L, Meyer R, Nagapudi K, Lin HH, Leavesley I, Jayanth J, Bajwa G, DiNunzio J, Tantuccio A, Blackwood D, Abebe A.

J Pharm Sci. 2017 Apr;106(4):930-943. doi: 10.1016/j.xphs.2016.12.014. Epub 2017 Jan 6.

PMID: 28069357

 

Identification of by-products in support of process development of Muraglitazar.

Pathirana C, Rusowicz A, Suda R, Swaminathan S, Palaniswamy V.

Magn Reson Chem. 2017 Apr;55(4):283-288. doi: 10.1002/mrc.4412. Epub 2016 Feb 17. No abstract available.

PMID: 26891263

 

Designer vaccine nanodiscs for personalized cancer immunotherapy.

Kuai R, Ochyl LJ, Bahjat KS, Schwendeman A, Moon JJ.

Nat Mater. 2017 Apr;16(4):489-496. doi: 10.1038/nmat4822. Epub 2016 Dec 26.

PMID: 28024156

 

Interference from Proteins and Surfactants on Particle Size Distributions Measured by Nanoparticle Tracking Analysis (NTA).

Bai K, Barnett GV, Kar SR, Das TK.

Pharm Res. 2017 Apr;34(4):800-808. doi: 10.1007/s11095-017-2109-3. Epub 2017 Feb 2.

PMID: 28155075

 

Generation of a clonal induced pluripotent stem cell (iPSC) line expressing the mutant MECP2 allele from a Rett Syndrome patient fibroblast line.

Hunihan L, Brown J, Cacace A, Fernandes A, Weston A.

Stem Cell Res. 2017 Apr;20:67-69. doi: 10.1016/j.scr.2017.02.017. Epub 2017 Mar 7.

PMID: 28395743

 

Regulatory Forum Opinion Piece_*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

Morgan SJ, Couch J, Guzzie-Peck P, Keller DA, Kemper R, Otieno MA, Schulingkamp RJ, Jones TW.

Toxicol Pathol. 2017 Apr;45(3):372-380. doi: 10.1177/0192623317701004. Epub 2017 Mar 28.

PMID: 28351296

 

Accounting for Cured Patients in Cost-Effectiveness Analysis.

Othus M, Bansal A, Koepl L, Wagner S, Ramsey S.

Value Health. 2017 Apr;20(4):705-709. doi: 10.1016/j.jval.2016.04.011. Epub 2016 Jun 9.

PMID: 28408015

 

Peptide Macrocyclization Inspired by Non-Ribosomal Imine Natural Products.

Malins LR, deGruyter JN, Robbins KJ, Scola PM, Eastgate MD, Ghadiri MR, Baran PS.

J Am Chem Soc. 2017 Mar 31. doi: 10.1021/jacs.7b01624. [Epub ahead of print]

PMID: 28326777

 

Daclatasvir/Asunaprevir/Beclabuvir (DCV-TRIO), All-Oral, Fixed-Dose Combination for Patients With Chronic HCV Genotype 1.

Kao JH, Yu ML, Peng CY, Heo J, Chu CJ, Chang TT, Lee YJ, Hu TH, Yoon KT, Paik SW, Lim YS, Ahn SH, Isakov V, McPhee F, Hu W, Swenson ES, Yin PD, Treitel M.

J Gastroenterol Hepatol. 2017 Mar 31. doi: 10.1111/jgh.13796. [Epub ahead of print]

PMID: 28370350

 

Modulators of Sphingosine-1-phosphate Pathway Biology: Recent Advances of Sphingosine-1-phosphate Receptor 1 (S1P₁) Agonists and Future Perspectives.

Dyckman AJ.

J Med Chem. 2017 Mar 30. doi: 10.1021/acs.jmedchem.6b01575. [Epub ahead of print]

PMID: 28291340

 

Antiviral Activity, Safety, and Exposure-Response relationships of GSK3532795, a Second-Generation HIV-1 Maturation Inhibitor, administered as Monotherapy or in Combination with Atazanavir±Ritonavir in a Phase 2a Randomized, Dose-Ranging, Controlled Trial (AI468002).

Hwang C, Schürmann D, Sobotha C, Boffito M, Sevinsky H, Ray N, Ravindran P, Xiao H, Keicher C, Hüser A, Krystal M, Dicker IB, Grasela D, Lataillade M.

Clin Infect Dis. 2017 Mar 23. doi: 10.1093/cid/cix239. [Epub ahead of print]

PMID: 28369211

 

Development of New Benzenesulfonamides As Potent and Selective Na_v1.7 Inhibitors for the Treatment of Pain.

Wu YJ, Guernon J, Shi J, Ditta J, Robbins KJ, Rajamani R, Easton A, Newton A, Bourin C, Mosure K, Soars MG, Knox RJ, Matchett M, Pieschl RL, Post-Munson DJ, Wang S, Herrington J, Graef J, Newberry K, Bristow LJ, Meanwell NA, Olson R, Thompson LA, Dzierba C.

J Med Chem. 2017 Mar 23;60(6):2513-2525. doi: 10.1021/acs.jmedchem.6b01918. Epub 2017 Mar 10.

PMID: 28234467

 

Endogenous opioids regulate moment-to-moment neuronal communication and excitability.

Winters BL, Gregoriou GC, Kissiwaa SA, Wells OA, Medagoda DI, Hermes SM, Burford NT, Alt A, Aicher SA, Bagley EE.

Nat Commun. 2017 Mar 22;8:14611. doi: 10.1038/ncomms14611.

PMID: 28327612

 

Extended release of flurbiprofen from tromethamine-buffered HPMC hydrophilic matrix tablets.

Pygall S, Kujawinski S, Timmins P, Melia C.

Pharm Dev Technol. 2017 Mar 16:1-8. doi: 10.1080/10837450.2017.1301470. [Epub ahead of print]

PMID: 28298171

 

A novel reagent significantly improved assay robustness in imaged capillary isoelectric focusing.

Zhang X, Voronov S, Mussa N, Li Z.

Anal Biochem. 2017 Mar 15;521:1-7. doi: 10.1016/j.ab.2016.12.013. Epub 2017 Jan 6.

PMID: 28065577

 

B-973, a novel piperazine positive allosteric modulator of the α7 nicotinic acetylcholine receptor.

Post-Munson DJ, Pieschl RL, Molski TF, Graef JD, Hendricson AW, Knox RJ, McDonald IM, Olson RE, Macor JE, Weed MR, Bristow LJ, Kiss L, Ahlijanian MK, Herrington J.

Eur J Pharmacol. 2017 Mar 15;799:16-25. doi: 10.1016/j.ejphar.2017.01.037. Epub 2017 Jan 26.

PMID: 28132910

 

Unmasking the Role of Uptake Transporters for Digoxin Uptake Across the Barriers of the Central Nervous System in Rat.

Taskar KS, Mariappan TT, Kurawattimath V, Singh Gautam S, Radhakrishna Mullapudi TV, Sridhar SK, Kallem RR, Marathe P, Mandlekar S.

J Cent Nerv Syst Dis. 2017 Mar 15;9:1179573517693596. doi: 10.1177/1179573517693596. eCollection 2017.

PMID: 28469522

 

Randomized phase 3 study of elotuzumab for relapsed or refractory multiple myeloma: ELOQUENT-2 Japanese patient subanalysis.

Suzuki K, Sunami K, Ohashi K, Iida S, Mori T, Handa H, Matsue K, Miyoshi M, Bleickardt E, Matsumoto M, Taniwaki M.

Blood Cancer J. 2017 Mar 10;7(3):e540. doi: 10.1038/bcj.2017.18. No abstract available.

PMID: 28282035

 

A Prospective, Multi-institutional, Pathologist-Based Assessment of 4 Immunohistochemistry Assays for PD-L1 Expression in Non-Small Cell Lung Cancer.

Rimm DL, Han G, Taube JM, Yi ES, Bridge JA, Flieder DB, Homer R, West WW, Wu H, Roden AC, Fujimoto J, Yu H, Anders R, Kowalewski A, Rivard C, Rehman J, Batenchuk C, Burns V, Hirsch FR, Wistuba II.

JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0013. [Epub ahead of print]

PMID: 28278348

 

CD6 as a potential target for treating multiple sclerosis.

Li Y, Singer NG, Whitbred J, Bowen MA, Fox DA, Lin F.

Proc Natl Acad Sci U S A. 2017 Mar 7;114(10):2687-2692. doi: 10.1073/pnas.1615253114. Epub 2017 Feb 16.

PMID: 28209777

 

CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.

Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators.

Eur Urol. 2017 Mar 3. pii: S0302-2838(17)30099-4. doi: 10.1016/j.eururo.2017.02.010. [Epub ahead of print]

PMID: 28262413

 

The role of chromatographic and chiroptical spectroscopic techniques and methodologies in support of drug discovery for atropisomeric drug inhibitors of Bruton's tyrosine kinase.

Dai J, Wang C, Traeger SC, Discenza L, Obermeier MT, Tymiak AA, Zhang Y.

J Chromatogr A. 2017 Mar 3;1487:116-128. doi: 10.1016/j.chroma.2017.01.016. Epub 2017 Jan 6.

PMID: 28131592

 

Nickel-Catalyzed Synthesis of Quinazolinediones.

Beutner GL, Hsiao Y, Razler T, Simmons EM, Wertjes W.

Org Lett. 2017 Mar 3;19(5):1052-1055. doi: 10.1021/acs.orglett.7b00052. Epub 2017 Feb 13.

PMID: 28253632

 

Genetic Regulation of Adipose Gene Expression and Cardio-Metabolic Traits.

Civelek M, Wu Y, Pan C, Raulerson CK, Ko A, He A, Tilford C, Saleem NK, Stančáková A, Scott LJ, Fuchsberger C, Stringham HM, Jackson AU, Narisu N, Chines PS, Small KS, Kuusisto J, Parks BW, Pajukanta P, Kirchgessner T, Collins FS, Gargalovic PS, Boehnke M, Laakso M, Mohlke KL, Lusis AJ.

Am J Hum Genet. 2017 Mar 2;100(3):428-443. doi: 10.1016/j.ajhg.2017.01.027.

PMID: 28257690

 

Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development.

Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A.

AAPS J. 2017 Mar;19(2):377-385. doi: 10.1208/s12248-016-0030-z. Epub 2017 Jan 12.

PMID: 28083796

 

An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab.

Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M.

AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.

PMID: 28070715

 

Use of Spray-Dried Dispersions in Early Pharmaceutical Development: Theoretical and Practical Challenges.

Li J, Patel D, Wang G.

AAPS J. 2017 Mar;19(2):321-333. doi: 10.1208/s12248-016-0017-9. Epub 2016 Nov 28.

PMID: 27896684

 

Population Pharmacokinetics of an Extended-Release Formulation of Exenatide Following Single- and Multiple-Dose Administration.

Cirincione B, Edwards J, Mager DE.

AAPS J. 2017 Mar;19(2):487-496. doi: 10.1208/s12248-016-9975-1. Epub 2016 Nov 28.

PMID: 27896683

 

Anemia is associated with bleeding and mortality, but not stroke, in patients with atrial fibrillation: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.

Westenbrink BD, Alings M, Granger CB, Alexander JH, Lopes RD, Hylek EM, Thomas L, Wojdyla DM, Hanna M, Keltai M, Steg PG, De Caterina R, Wallentin L, van Gilst WH.

Am Heart J. 2017 Mar;185:140-149. doi: 10.1016/j.ahj.2016.12.008. Epub 2016 Dec 22.

PMID: 28267467

 

Design and synthesis of a novel series of 4-heteroarylamino-1'-azaspiro[oxazole-5,3'-bicyclo[2.2.2]octanes as α7 nicotinic receptor agonists 2. Development of 4-heteroaryl SAR.

Iwuagwu C, King D, McDonald IM, Cook J, Zusi FC, Hill MD, Mate RA, Fang H, Knox R, Gallagher L, Post-Munson Amy Easton D, Miller R, Benitex Y, Siuciak J, Lodge N, Zaczek R, Morgan D, Bristow L, Macor JE, Olson RE.

Bioorg Med Chem Lett. 2017 Mar 1;27(5):1261-1266. doi: 10.1016/j.bmcl.2017.01.058. Epub 2017 Jan 20.

PMID: 28169167

 

Systematic interpolation method predicts protein chromatographic elution with salt gradients, pH gradients and combined salt/pH gradients.

Creasy A, Barker G, Carta G.

Biotechnol J. 2017 Mar;12(3). doi: 10.1002/biot.201600636. Epub 2017 Jan 24.

PMID: 27992113

 

Characterization of TAP Ambr 250 disposable bioreactors, as a reliable scale-down model for biologics process development.

Xu P, Clark C, Ryder T, Sparks C, Zhou J, Wang M, Russell R, Scott C.

Biotechnol Prog. 2017 Mar;33(2):478-489. doi: 10.1002/btpr.2417. Epub 2017 Feb 6.

PMID: 27977912

 

Population pharmacokinetics of exenatide.

Cirincione B, Mager DE.

Br J Clin Pharmacol. 2017 Mar;83(3):517-526. doi: 10.1111/bcp.13135. Epub 2016 Nov 16.

PMID: 27650681

 

Asunaprevir: An HCV Protease Inhibitor With Preferential Liver Distribution.

Eley T, Garimella T, Li W, Bertz RJ.

Clin Pharmacol Drug Dev. 2017 Mar;6(2):195-200. doi: 10.1002/cpdd.315.

PMID: 28263460

 

Harmonizing Global Biospecimen Consent Practices to Advance Translational Research: A Call to Action.

Warner AW, Moore H, Reinhard D, Ball LA, Knoppers BM.

Clin Pharmacol Ther. 2017 Mar;101(3):317-319. doi: 10.1002/cpt.461. Epub 2016 Sep 28.

PMID: 27558027

 

Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial.

Restelli U, Fabbiani M, Di Giambenedetto S, Nappi C, Croce D.

Clinicoecon Outcomes Res. 2017 Mar 1;9:173-179. doi: 10.2147/CEOR.S127097. eCollection 2017. Erratum in: Clinicoecon Outcomes Res. 2017 Apr 19;9:231.

PMID: 28280375

 

Readmission Risk in Chronic Obstructive Pulmonary Disease Patients: Comparative Study of Nebulized β₂-Agonists.

Bollu V, Guérin A, Gauthier G, Hiscock R, Wu EQ.

Drugs Real World Outcomes. 2017 Mar;4(1):33-41. doi: 10.1007/s40801-016-0097-y.

PMID: 27864792

 

Single jugular vein cannulated rats may not be suitable for intravenous pharmacokinetic screening of high logP compounds.

Gaud N, Kumar A, Matta M, Kole P, Sridhar S, Mandlekar S, Holenarsipur VK.

Eur J Pharm Sci. 2017 Mar 1;99:272-278. doi: 10.1016/j.ejps.2016.12.025. Epub 2016 Dec 26.

PMID: 28034694

 

Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.

Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Côté P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P.

Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.

PMID: 28210927

 

Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study.

Iida S, Nagai H, Kinoshita G, Miyoshi M, Robbins M, Pandya D, Bleickardt E, Chou T.

Int J Hematol. 2017 Mar;105(3):326-334. doi: 10.1007/s12185-016-2138-4. Epub 2016 Nov 15.

PMID: 27848182

 

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma.

Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C.

J Clin Oncol. 2017 Mar;35(7):785-792. doi: 10.1200/JCO.2015.66.1389. Epub 2016 Nov 14.

PMID: 28068177

 

Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors.

Agrawal S, Statkevich P, Bajaj G, Feng Y, Saeger S, Desai DD, Park JS, Waxman IM, Roy A, Gupta M.

J Clin Pharmacol. 2017 Mar;57(3):394-400. doi: 10.1002/jcph.818. Epub 2016 Sep 27.

PMID: 27557786

 

Daclatasvir/asunaprevir/beclabuvir fixed-dose combination in Japanese patients with HCV genotype 1 infection.

Toyota J, Karino Y, Suzuki F, Ikeda F, Ido A, Tanaka K, Takaguchi K, Naganuma A, Tomita E, Chayama K, Fujiyama S, Inada Y, Yoshiji H, Watanabe H, Ishikawa H, Hu W, McPhee F, Linaberry M, Yin PD, Swenson ES, Kumada H.

J Gastroenterol. 2017 Mar;52(3):385-395. doi: 10.1007/s00535-016-1245-6. Epub 2016 Aug 9.

PMID: 27502287

 

Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients.

Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S.

J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

PMID: 28282271

 

Synthesis of unlabelled and stable-isotope-labelled glucuronide metabolites of dapagliflozin and synthesis of stable-isotope-labelled dapagliflozin.

Cao K, Brailsford JA, Yao M, Caceres-Cortes J, Espina R, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2017 Mar;60(3):150-159. doi: 10.1002/jlcr.3484. Epub 2017 Feb 1.

PMID: 27868223

 

Inhibition Mediated by Glycinergic and GABAergic Receptors on Excitatory Neurons in Mouse Superficial Dorsal Horn Is Location-Specific but Modified by Inflammation.

Takazawa T, Choudhury P, Tong CK, Conway CM, Scherrer G, Flood PD, Mukai J, MacDermott AB.

J Neurosci. 2017 Mar 1;37(9):2336-2348. doi: 10.1523/JNEUROSCI.2354-16.2017. Epub 2017 Jan 27.

PMID: 28130358

 

Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial.

Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bottomley A, Kotapati S, de Pril V, Testori A, Eggermont AM.

Lancet Oncol. 2017 Mar;18(3):393-403. doi: 10.1016/S1470-2045(17)30015-3. Epub 2017 Feb 3.

PMID: 28162999

 

Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial.

Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JÁ, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD.

Lancet Oncol. 2017 Mar;18(3):312-322. doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26.

PMID: 28131785

 

Advances in analytical methodologies to guide bioprocess engineering for bio-therapeutics.

Saldova R, Kilcoyne M, Stöckmann H, Millán Martín S, Lewis AM, Tuite CM, Gerlach JQ, Le Berre M, Borys MC, Li ZJ, Abu-Absi NR, Leister K, Joshi L, Rudd PM.

Methods. 2017 Mar 1;116:63-83. doi: 10.1016/j.ymeth.2016.11.002. Epub 2016 Nov 8.

PMID: 27832969

 

Novel platens to measure the hardness of a pentagonal shaped tablet.

Malladi J, Sidik K, Wu S, McCann R, Dougherty J, Parab P, Carragher T.

Pharm Dev Technol. 2017 Mar;22(2):246-255. doi: 10.1080/10837450.2016.1219370. Epub 2016 Oct 4.

PMID: 27607150

 

Effects of Histidine and Sucrose on the Biophysical Properties of a Monoclonal Antibody.

Baek Y, Singh N, Arunkumar A, Zydney AL.

Pharm Res. 2017 Mar;34(3):629-639. doi: 10.1007/s11095-016-2092-0. Epub 2016 Dec 29.

PMID: 28035628

 

Meal Effects Confound Attempts to Counteract Rabeprazole-Induced Hypochlorhydria Decreases in Atazanavir Absorption.

Faber KP, Wu HF, Yago MR, Xu X, Kadiyala P, Frassetto LA, Benet LZ.

Pharm Res. 2017 Mar;34(3):619-628. doi: 10.1007/s11095-016-2090-2. Epub 2016 Dec 27.

PMID: 28028768

 

Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease.

Herzer K, Welzel TM, Spengler U, Hinrichsen H, Klinker H, Berg T, Ferenci P, Peck-Radosavljevic M, Inderson A, Zhao Y, Jimenez-Exposito MJ, Zeuzem S.

Transpl Int. 2017 Mar;30(3):243-255. doi: 10.1111/tri.12910.

PMID: 28012215

 

The effect of apixaban on the pharmacokinetics of digoxin and atenolol in healthy subjects.

Frost C, Song Y, Yu Z, Wang J, Lee LS, Schuster A, Pollack A, LaCreta F.

Clin Pharmacol. 2017 Feb 23;9:19-28. doi: 10.2147/CPAA.S115687. eCollection 2017.

PMID: 28260951

 

Discovery of Pyrrolidine-Containing GPR40 Agonists: Stereochemistry Effects a Change in Binding Mode.

Jurica EA, Wu X, Williams KN, Hernandez AS, Nirschl DS, Rampulla RA, Mathur A, Zhou M, Cao G, Xie C, Jacob B, Cai H, Wang T, Murphy BJ, Liu H, Xu C, Kunselman LK, Hicks MB, Sun Q, Schnur DM, Sitkoff DF, Dierks EA, Apedo A, Moore DB, Foster KA, Cvijic ME, Panemangalore R, Flynn NA, Maxwell BD, Hong Y, Tian Y, Wilkes JJ, Zinker BA, Whaley JM, Barrish JC, Robl JA, Ewing WR, Ellsworth BA.

J Med Chem. 2017 Feb 23;60(4):1417-1431. doi: 10.1021/acs.jmedchem.6b01559. Epub 2017 Feb 9.

PMID: 28112924

 

Eldelumab [anti-interferon-γ-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study.

Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A.

J Crohns Colitis. 2017 Feb 22. doi: 10.1093/ecco-jcc/jjx005. [Epub ahead of print]

PMID: 28333187

 

Mapping the Energetic Epitope of an Antibody/Interleukin-23 Interaction with Hydrogen/Deuterium Exchange, Fast Photochemical Oxidation of Proteins Mass Spectrometry, and Alanine Shave Mutagenesis.

Li J, Wei H, Krystek SR Jr, Bond D, Brender TM, Cohen D, Feiner J, Hamacher N, Harshman J, Huang RY, Julien SH, Lin Z, Moore K, Mueller L, Noriega C, Sejwal P, Sheppard P, Stevens B, Chen G, Tymiak AA, Gross ML, Schneeweis LA.

Anal Chem. 2017 Feb 21;89(4):2250-2258. doi: 10.1021/acs.analchem.6b03058. Epub 2017 Feb 9.

PMID: 28193005

 

The novel BMI-1 inhibitor PTC596 downregulates MCL-1 and induces p53-independent mitochondrial apoptosis in acute myeloid leukemia progenitor cells.

Nishida Y, Maeda A, Kim MJ, Cao L, Kubota Y, Ishizawa J, AlRawi A, Kato Y, Iwama A, Fujisawa M, Matsue K, Weetall M, Dumble M, Andreeff M, Davis TW, Branstrom A, Kimura S, Kojima K.

Blood Cancer J. 2017 Feb 17;7(2):e527. doi: 10.1038/bcj.2017.8.

PMID: 28211885

 

Catalytic intermolecular hydroaminations of unactivated olefins with secondary alkyl amines.

Musacchio AJ, Lainhart BC, Zhang X, Naguib SG, Sherwood TC, Knowles RR.

Science. 2017 Feb 17;355(6326):727-730. doi: 10.1126/science.aal3010.

PMID: 28209894

 

Discovery of 7-(3-(piperazin-1-yl)phenyl)pyrrolo[2,1-f][1,2,4]triazin-4-amine derivatives as highly potent and selective PI3Kδ inhibitors.

Qin LY, Ruan Z, Cherney RJ, Dhar TG, Neels J, Weigelt CA, Sack JS, Srivastava AS, Cornelius LA, Tino JA, Stefanski K, Gu X, Xie J, Susulic V, Yang X, Yarde-Chinn M, Skala S, Bosnius R, Goldstein C, Davies P, Ruepp S, Salter-Cid L, Bhide RS, Poss MA.

Bioorg Med Chem Lett. 2017 Feb 15;27(4):855-861. doi: 10.1016/j.bmcl.2017.01.016. Epub 2017 Jan 10.

PMID: 28108251

 

Functionalized triazines as potent HCV entry inhibitors.

Mull ES, Sun LQ, Zhao Q, Eggers B, Pokornowski K, Zhai G, Rajamani R, Jenkins S, Kramer M, Wang YK, Fang H, Tenney D, Baldick CJ, Cockett MI, Meanwell NA, Scola PM.

Bioorg Med Chem Lett. 2017 Feb 15;27(4):1089-1093. doi: 10.1016/j.bmcl.2016.12.038. Epub 2016 Dec 18.

PMID: 28089701

 

Effective Combination of Innate and Adaptive Immunotherapeutic Approaches in a Mouse Melanoma Model.

Rakhmilevich AL, Felder M, Lever L, Slowinski J, Rasmussen K, Hoefges A, Van De Voort TJ, Loibner H, Korman AJ, Gillies SD, Sondel PM.

J Immunol. 2017 Feb 15;198(4):1575-1584. doi: 10.4049/jimmunol.1601255. Epub 2017 Jan 6.

PMID: 28062694

 

Major Bleeding Complications and Persistence With Oral Anticoagulation in Non-Valvular Atrial Fibrillation: Contemporary Findings in Real-Life Danish Patients.

Lamberts M, Staerk L, Olesen JB, Fosbøl EL, Hansen ML, Harboe L, Lefevre C, Evans D, Gislason GH.

J Am Heart Assoc. 2017 Feb 14;6(2). pii: e004517. doi: 10.1161/JAHA.116.004517.

PMID: 28196815

 

Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study.

Alten R, Nüßlein HG, Mariette X, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M.

RMD Open. 2017 Feb 13;3(1):e000345. doi: 10.1136/rmdopen-2016-000345. eCollection 2017.

PMID: 28243468

 

BMS-933043, a Selective α7 nAChR Partial Agonist for the Treatment of Cognitive Deficits Associated with Schizophrenia.

King D, Iwuagwu C, Cook J, McDonald IM, Mate R, Zusi FC, Hill MD, Fang H, Zhao R, Wang B, Easton AE, Miller R, Post-Munson D, Knox RJ, Gallagher L, Westphal R, Molski T, Fan J, Clarke W, Benitex Y, Lentz KA, Denton R, Morgan D, Zaczek R, Lodge NJ, Bristow LJ, Macor JE, Olson RE.

ACS Med Chem Lett. 2017 Feb 8;8(3):366-371. doi: 10.1021/acsmedchemlett.7b00032. eCollection 2017 Mar 9.

PMID: 28337332

A mechanistic kinetic description of lactate dehydrogenase elucidating cancer diagnosis and inhibitor evaluation.

Tang P, Xu J, Oliveira CL, Li ZJ, Liu S.

J Enzyme Inhib Med Chem. 2017 Dec;32(1):564-571. doi: 10.1080/14756366.2016.1275606.

PMID: 28114833

 

Single jugular vein cannulated rats may not be suitable for intravenous pharmacokinetic screening of high logP compounds.

Gaud N, Kumar A, Matta M, Kole P, Sridhar S, Mandlekar S, Holenarsipur VK.

Eur J Pharm Sci. 2017 Mar 1;99:272-278. doi: 10.1016/j.ejps.2016.12.025.

PMID: 28034694

 

Effects of Histidine and Sucrose on the Biophysical Properties of a Monoclonal Antibody.

Baek Y, Singh N, Arunkumar A, Zydney AL.

Pharm Res. 2017 Mar;34(3):629-639. doi: 10.1007/s11095-016-2092-0.

PMID: 28035628

 

Meal Effects Confound Attempts to Counteract Rabeprazole-Induced Hypochlorhydria Decreases in Atazanavir Absorption.

Faber KP, Wu HF, Yago MR, Xu X, Kadiyala P, Frassetto LA, Benet LZ.

Pharm Res. 2017 Mar;34(3):619-628. doi: 10.1007/s11095-016-2090-2.

PMID: 28028768

 

Characterization of Phase Separation Propensity for Amorphous Spray Dried Dispersions.

McNamara D, Yin S, Pan D, Crull G, Timmins P, Vig B.

Mol Pharm. 2017 Feb 6;14(2):377-385. doi: 10.1021/acs.molpharmaceut.6b00722.

PMID: 28068097

 

Formation of α-chiral centers by asymmetric β-C(sp3)-H arylation, alkenylation, and alkynylation.

Wu QF, Shen PX, He J, Wang XB, Zhang F, Shao Q, Zhu RY, Mapelli C, Qiao JX, Poss MA, Yu JQ.

Science. 2017 Feb 3;355(6324):499-503. doi: 10.1126/science.aal5175.

PMID: 28154075

 

Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial.

Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bottomley A, Kotapati S, de Pril V, Testori A, Eggermont AM.

Lancet Oncol. 2017 Feb 2. pii: S1470-2045(17)30015-3. doi: 10.1016/S1470-2045(17)30015-3. [Epub ahead of print]

PMID: 28162999

 

Interference from Proteins and Surfactants on Particle Size Distributions Measured by Nanoparticle Tracking Analysis (NTA).

Bai K, Barnett GV, Kar SR, Das TK.

Pharm Res. 2017 Feb 2. doi: 10.1007/s11095-017-2109-3. [Epub ahead of print]

PMID: 28155075

 

A Rational Analysis of Uniformity Risk for Agglomerated Drug Substance Using NIR Chemical Imaging.

Scherholz ML, Wan B, McGeorge G.

AAPS PharmSciTech. 2017 Feb;18(2):432-440. doi: 10.1208/s12249-016-0523-1.

PMID: 27052406

 

Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users: analysis of patient electronic medical record data.

Rosenblatt L, Broder MS, Bentley TG, Chang E, Reddy SR, Papoyan E, Myers J.

AIDS Care. 2017 Feb 1:1-7. doi: 10.1080/09540121.2017.1280123. [Epub ahead of print]

PMID: 28147708

 

Ligand-Enabled β-C-H Arylation of α-Amino Acids Without Installing Exogenous Directing Groups.

Chen G, Zhuang Z, Li GC, Saint-Denis TG, Hsiao Y, Joe CL, Yu JQ.

Angew Chem Int Ed Engl. 2017 Feb 1;56(6):1506-1509. doi: 10.1002/anie.201610580.

PMID: 28052530

 

Structure-activity relationships of 4-hydroxy-4-biaryl-proline acylsulfonamide tripeptides: A series of potent NS3 protease inhibitors for the treatment of hepatitis C virus.

Wang AX, Chen J, Zhao Q, Sun LQ, Friborg J, Yu F, Hernandez D, Good AC, Klei HE, Rajamani R, Mosure K, Knipe JO, Li D, Zhu J, Levesque PC, McPhee F, Meanwell NA, Scola PM.

Bioorg Med Chem Lett. 2017 Feb 1;27(3):590-596. doi: 10.1016/j.bmcl.2016.12.013.

PMID: 28011221

 

Identification and optimization of a novel series of indoleamine 2,3-dioxygenase inhibitors.

Markwalder JA, Seitz SP, Blat Y, Elkin L, Hunt JT, Pabalan JG, Jure-Kunkel MN, Vite GD, Covello K.

Bioorg Med Chem Lett. 2017 Feb 1;27(3):582-585. doi: 10.1016/j.bmcl.2016.12.015.

PMID: 28003141

 

Development of spiroguanidine-derived α7 neuronal nicotinic receptor partial agonists.

Hill MD, Fang H, Digavalli SV, Healy FL, Gallagher L, Post-Munson D, Chen P, Natale J, Benitex Y, Morgan D, Lodge N, Bristow L, Macor JE, Olson RE.

Bioorg Med Chem Lett. 2017 Feb 1;27(3):578-581. doi: 10.1016/j.bmcl.2016.12.014.

PMID: 27993517

 

Use of a cocktail probe to assess potential drug interactions with cytochrome P450 after administration of belatacept, a costimulatory immunomodulator.

Williams D, Tao X, Zhu L, Stonier M, Lutz JD, Masson E, Zhang S, Ganguly B, Tzogas Z, Lubin S, Murthy B.

Br J Clin Pharmacol. 2017 Feb;83(2):370-380. doi: 10.1111/bcp.13097.

PMID: 27552251

 

Dasatinib Changes Immune Cell Profiles Concomitant with Reduced Tumor Growth in Several Murine Solid Tumor Models.

Hekim C, Ilander M, Yan J, Michaud E, Smykla R, Vähä-Koskela M, Savola P, Tähtinen S, Saikko L, Hemminki A, Kovanen PE, Porkka K, Lee FY, Mustjoki S.

Cancer Immunol Res. 2017 Feb;5(2):157-169. doi: 10.1158/2326-6066.CIR-16-0061-T.

PMID: 28073775

 

Temporally Distinct PD-L1 Expression by Tumor and Host Cells Contributes to Immune Escape.

Noguchi T, Ward JP, Gubin MM, Arthur CD, Lee SH, Hundal J, Selby MJ, Graziano RF, Mardis ER, Korman AJ, Schreiber RD.

Cancer Immunol Res. 2017 Feb;5(2):106-117. doi: 10.1158/2326-6066.CIR-16-0391.

PMID: 28073774

 

Oncology Nurse Navigation: Results of the 2016 Role Delineation Study.

Lubejko BG, Bellfield S, Kahn E, Lee C, Peterson N, Rose T, Murphy CM, McCorkle M.

Clin J Oncol Nurs. 2017 Feb 1;21(1):43-50. doi: 10.1188/17.CJON.43-50.

PMID: 28107327

 

Organic Anion Transporter 2: An Enigmatic Human Solute Carrier.

Shen H, Lai Y, Rodrigues AD.

Drug Metab Dispos. 2017 Feb;45(2):228-236. doi: 10.1124/dmd.116.072264.

PMID: 27872146

 

A clinician's guide to the cost and health benefits of hepatitis C cure assessed from the individual patient perspective.

McEwan P, Selvapatt N, Brown A, Thursz M, Bennett H, Webster S, Kalsekar A, Yuan Y, Brenner M, Gordon J.

Eur J Gastroenterol Hepatol. 2017 Feb;29(2):208-214. doi: 10.1097/MEG.0000000000000773.

PMID: 27832039

 

CYP2C19 Genotype-Dependent Pharmacokinetic Drug Interaction Between Voriconazole and Ritonavir-Boosted Atazanavir in Healthy Subjects.

Zhu L, Brüggemann RJ, Uy J, Colbers A, Hruska MW, Chung E, Sims K, Vakkalagadda B, Xu X, van Schaik RH, Burger DM, Bertz RJ.

J Clin Pharmacol. 2017 Feb;57(2):235-246. doi: 10.1002/jcph.798.

PMID: 27432796

 

Pharmacokinetic, Pharmacodynamic, and Safety Profile of a Novel Anti-CD28 Domain Antibody Antagonist in Healthy Subjects.

Shi R, Honczarenko M, Zhang S, Fleener C, Mora J, Lee SK, Wang R, Liu X, Shevell DE, Yang Z, Wang H, Murthy B.

J Clin Pharmacol. 2017 Feb;57(2):161-172. doi: 10.1002/jcph.791.

PMID: 27402064

 

Selective IRAK4 Inhibition Attenuates Disease in Murine Lupus Models and Demonstrates Steroid Sparing Activity.

Dudhgaonkar S, Ranade S, Nagar J, Subramani S, Prasad DS, Karunanithi P, Srivastava R, Venkatesh K, Selvam S, Krishnamurthy P, Mariappan TT, Saxena A, Fan L, Stetsko DK, Holloway DA, Li X, Zhu J, Yang WP, Ruepp S, Nair S, Santella J, Duncia J, Hynes J, McIntyre KW, Carman JA.

J Immunol. 2017 Feb 1;198(3):1308-1319. doi: 10.4049/jimmunol.1600583.

PMID: 28003376

 

Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing.

Meena AK, Desai D, Serajuddin AT.

J Pharm Sci. 2017 Feb;106(2):589-600. doi: 10.1016/j.xphs.2016.10.020.

PMID: 27890244

 

Tenofovir Disoproxil Fumarate Is Not an Inhibitor of Human Organic Cation Transporter 1.

Shen H, Li W, Humphreys WG, Lai Y.

J Pharmacol Exp Ther. 2017 Feb;360(2):341-342. doi: 10.1124/jpet.116.238337. No abstract available.

PMID: 28104831

 

PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project.

Hirsch FR, McElhinny A, Stanforth D, Ranger-Moore J, Jansson M, Kulangara K, Richardson W, Towne P, Hanks D, Vennapusa B, Mistry A, Kalamegham R, Averbuch S, Novotny J, Rubin E, Emancipator K, McCaffery I, Williams JA, Walker J, Longshore J, Tsao MS, Kerr KM.

J Thorac Oncol. 2017 Feb;12(2):208-222. doi: 10.1016/j.jtho.2016.11.2228.

PMID: 27913228

 

Chronic hepatitis C virus infection and the risk for diabetes: a community-based prospective study.

Lin YJ, Shaw TG, Yang HI, Lu SN, Jen CL, Wang LY, Wong KH, Chan SY, Yuan Y, L'Italien G, Chen CJ, Lee MH; R.E.V.E.A.L.-HCV Study Group..

Liver Int. 2017 Feb;37(2):179-186. doi: 10.1111/liv.13194.

PMID: 27363856

 

An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1.

Cogswell J, Inzunza HD, Wu Q, Feder JN, Mintier G, Novotny J, Cardona DM.

Mol Diagn Ther. 2017 Feb;21(1):85-93. doi: 10.1007/s40291-016-0237-9.

PMID: 27667773

 

Risk of hepatitis C virus related hepatocellular carcinoma between subjects with spontaneous and treatment-induced viral clearance.

Huang CF, Yeh ML, Huang CI, Lin YJ, Tsai PC, Lin ZY, Chan SY, Chen SC, Yang HI, Huang JF, Lu SN, Dai CY, Jen CL, Yuan Y, L'Italien G, Wang LY, Lee MH, Yu ML, Chuang WL, Chen CJ.

Oncotarget. 2017 Feb 1. doi: 10.18632/oncotarget.14937. [Epub ahead of print]

PMID: 28159934

 

Mechanisms for Hepatobiliary Toxicity in Rats Treated with an Antagonist of Melanin Concentrating Hormone Receptor 1 (MCHR1).

Otieno MA, Bhaskaran V, Janovitz E, Callejas Y, Foster WB, Washburn W, Megill JR, Lehman-McKeeman L, Gemzik B.

Toxicol Sci. 2017 Feb;155(2):379-388. doi: 10.1093/toxsci/kfw216.

PMID: 28025230

 

From the Cover: Investigative Nonclinical Cardiovascular Safety and Toxicology Studies with BMS-986094, an NS5b RNA-Dependent RNA Polymerase Inhibitor.

Gill M, Horn K, Hennan J, White R, Bounous D, Clark S, Megill JR, Janovitz E, Davies M, Sanderson T, Graziano M.

Toxicol Sci. 2017 Feb;155(2):348-362. doi: 10.1093/toxsci/kfw211.

PMID: 27864544

 

Structure-Based Design of Macrocyclic Factor XIa Inhibitors: Discovery of the Macrocyclic Amide Linker.

Corte JR, Fang T, Osuna H, Pinto DJ, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Zheng JJ, Harper TW, Bozarth JM, Wu Y, Luettgen JM, Seiffert DA, Decicco CP, Wexler RR, Quan ML.

J Med Chem. 2017 Jan 31. doi: 10.1021/acs.jmedchem.6b01460. [Epub ahead of print]

PMID: 28085275

 

Cost-effectiveness Analysis for Apixaban in the Acute Treatment and Prevention of Venous Thromboembolism in the Netherlands.

de Jong LA, Dvortsin E, Janssen KJ, Postma MJ.

Clin Ther. 2017 Jan 27. pii: S0149-2918(16)30925-0. doi: 10.1016/j.clinthera.2016.12.012. [Epub ahead of print]

PMID: 28139289

 

Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype.

Goolsby Hunter A, Rosenblatt L, Patel C, Blauer-Peterson C, Anduze-Faris B.

Curr Med Res Opin. 2017 Jan 27:1-24. doi: 10.1080/03007995.2017.1288613. [Epub ahead of print]

PMID: 28128648

 

Inhibition mediated by glycinergic and GABAergic receptors on excitatory neurons in mouse superficial dorsal horn is location specific but modified by inflammation.

Takazawa T, Choudhury P, Tong CK, Conway CM, Scherrer G, Flood PD, Mukai J, MacDermott AB.

J Neurosci. 2017 Jan 27. pii: 2354-16. doi: 10.1523/JNEUROSCI.2354-16.2017. [Epub ahead of print]

PMID: 28130358

 

Ligand and Target Discovery by Fragment-Based Screening in Human Cells.

Parker CG, Galmozzi A, Wang Y, Correia BE, Sasaki K, Joslyn CM, Kim AS, Cavallaro CL, Lawrence RM, Johnson SR, Narvaiza I, Saez E, Cravatt BF.

Cell. 2017 Jan 26;168(3):527-541.e29. doi: 10.1016/j.cell.2016.12.029.

PMID: 28111073

 

B-973, a novel piperazine positive allosteric modulator of the α7 nicotinic acetylcholine receptor.

Post-Munson DJ, Pieschl RL, Molski TF, Graef JD, Hendricson AW, Knox RJ, McDonald IM, Olson RE, Macor JE, Weed MR, Bristow LJ, Kiss L, Ahlijanian MK, Herrington J.

Eur J Pharmacol. 2017 Jan 26. pii: S0014-2999(17)30046-8. doi: 10.1016/j.ejphar.2017.01.037. [Epub ahead of print]

PMID: 28132910

 

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

Hennig M, Hundt F, Busta S, Mikus S, Sanden PH, Sörgel A, Ruppert T.

Ger Med Sci. 2017 Jan 26;15:Doc02. doi: 10.3205/000243.

PMID: 28163667

 

Objective Response by mRECIST as a Predictor and Potential Surrogate End Point of Overall Survival in Advanced HCC.

Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Ríos J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM.

J Hepatol. 2017 Jan 25. pii: S0168-8278(17)30016-8. doi: 10.1016/j.jhep.2017.01.012. [Epub ahead of print]

PMID: 28131794

 

Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial.

Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JÁ, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD.

Lancet Oncol. 2017 Jan 25. pii: S1470-2045(17)30065-7. doi: 10.1016/S1470-2045(17)30065-7. [Epub ahead of print]

PMID: 28131785

 

Cost-effectiveness of apixaban versus low molecular weight heparin/vitamin k antagonist for the treatment of venous thromboembolism and the prevention of recurrences.

Lanitis T, Leipold R, Hamilton M, Rublee D, Quon P, Browne C, Cohen AT.

BMC Health Serv Res. 2017 Jan 23;17(1):74. doi: 10.1186/s12913-017-1995-8.

PMID: 28114939

 

Drug-to-antibody determination for an antibody-drug-conjugate utilizing cathepsin B digestion coupled with reversed-phase high-pressure liquid chromatography analysis.

Adamo M, Sun G, Qiu D, Valente J, Lan W, Song H, Bolgar M, Katiyar A, Krishnamurthy G.

J Chromatogr A. 2017 Jan 20;1481:44-52. doi: 10.1016/j.chroma.2016.12.051.

PMID: 28017567

 

Biomarkers of extracellular matrix turnover are associated with emphysema and eosinophilic-bronchitis in COPD.

Bihlet AR, Karsdal MA, Sand JM, Leeming DJ, Roberts M, White W, Bowler R.

Respir Res. 2017 Jan 19;18(1):22. doi: 10.1186/s12931-017-0509-x.

PMID: 28103932

 

 Dapagliflozin in Patients with Type 1 Diabetes: A post-hoc analysis of the effect of insulin dose adjustments on 24-hour continuously monitored mean glucose and fasting beta-hydroxybutyrate levels from a Phase IIa pilot study.

Henry RR, Dandona P, Pettus J, Mudaliar S, Xu J, Hansen L.

Diabetes Obes Metab. 2017 Jan 18. doi: 10.1111/dom.12882. [Epub ahead of print]

PMID: 28098426

 

[Economic impact of optimising antiretroviral treatment in human immunodeficiency virus-infected adults with suppressed viral load in Spain, by implementing the grade A-1 evidence recommendations of the 2015 GESIDA/National AIDS Plan].

Ribera E, Martínez-Sesmero JM, Sánchez-Rubio J, Rubio R, Pasquau J, Poveda JL, Pérez-Mitru A, Roldán C, Hernández-Novoa B.

Enferm Infecc Microbiol Clin. 2017 Jan 18. pii: S0213-005X(16)30396-2. doi: 10.1016/j.eimc.2016.11.015. [Epub ahead of print] Spanish.

PMID: 28109551

 

Diverse ortho-C(sp₂)-H Functionalization of Benzaldehydes Using Transient Directing Groups.

Liu XH, Park H, Hu JH, Hu Y, Zhang QL, Wang BL, Sun B, Yeung KS, Zhang FL, Yu JQ.

J Am Chem Soc. 2017 Jan 18;139(2):888-896. doi: 10.1021/jacs.6b11188.

PMID: 28006102

 

Fc-Silent Anti-CD154 Domain Antibody Effectively Prevents Non-Human Primate Renal Allograft Rejection.

Kim SC, Wakwe W, Higginbotham LB, Mathews DV, Breeden CP, Stephenson AC, Jenkins J, Strobert E, Price K, Price L, Kuhn R, Wang H, Yamniuk A, Suchard S, Farris AB 3rd, Pearson TC, Larsen CP, Ford ML, Suri A, Nadler S, Adams AB.

Am J Transplant. 2017 Jan 17. doi: 10.1111/ajt.14197. [Epub ahead of print]

PMID: 28097811

 

Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial.

Hu PT, Lopes RD, Stevens SR, Wallentin L, Thomas L, Alexander JH, Hanna M, Lewis BS, Verheugt FW, Granger CB, Jones WS.

J Am Heart Assoc. 2017 Jan 17;6(1). pii: e004699. doi: 10.1161/JAHA.116.004699.

PMID: 28096100

 

Real-time observation of protein aggregates in pharmaceutical formulations using liquid cell electron microscopy.

DiMemmo LM, Cameron Varano A, Haulenbeek J, Liang Y, Patel K, Dukes MJ, Zheng S, Hubert M, Piccoli SP, Kelly DF.

Lab Chip. 2017 Jan 17;17(2):315-322. doi: 10.1039/c6lc01160h.

PMID: 27934977

 

Decarboxylative Peptide Macrocyclization through Photoredox Catalysis.

McCarver SJ, Qiao JX, Carpenter J, Borzilleri RM, Poss MA, Eastgate MD, Miller MM, MacMillan DW.

Angew Chem Int Ed Engl. 2017 Jan 16;56(3):728-732. doi: 10.1002/anie.201608207.

PMID: 27860140

 

Triazolopyridine ethers as potent, orally active mGlu₂ positive allosteric modulators for treating schizophrenia.

Higgins MA, Marcin LR, Christopher Zusi F, Gentles R, Ding M, Pearce BC, Easton A, Kostich WA, Seager MA, Bourin C, Bristow LJ, Johnson KA, Miller R, Hogan J, Whiterock V, Gulianello M, Ferrante M, Huang Y, Hendricson A, Alt A, Macor JE, Bronson JJ.

Bioorg Med Chem. 2017 Jan 15;25(2):496-513. doi: 10.1016/j.bmc.2016.11.018.

PMID: 27914948

 

Discovery and initial optimization of alkoxyanthranilic acid derivatives as inhibitors of HCV NS5B polymerase.

Parcella K, Nickel A, Beno BR, Sheriff S, Wan C, Wang YK, Roberts SB, Meanwell NA, Kadow JF.

Bioorg Med Chem Lett. 2017 Jan 15;27(2):295-298. doi: 10.1016/j.bmcl.2016.11.054.

PMID: 27908764

 

Anticoagulation therapy and clinical outcomes in patients with recently diagnosed atrial fibrillation: Insights from the ARISTOTLE trial.

Guimarães PO, Wojdyla DM, Alexander JH, Thomas L, Alings M, Flaker GC, Al-Khatib SM, Hanna M, Horowitz JD, Wallentin L, Granger CB, Lopes RD.

Int J Cardiol. 2017 Jan 15;227:443-449. doi: 10.1016/j.ijcard.2016.11.014.

PMID: 27852444

 

Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development.

Salazar-Fontana LI, Desai DD, Khan TA, Pillutla RC, Prior S, Ramakrishnan R, Schneider J, Joseph A.

AAPS J. 2017 Jan 12. doi: 10.1208/s12248-016-0030-z. [Epub ahead of print]

PMID: 28083796

 

Journal of Medicinal Chemistry, Technological Advances: Highlights 2015-2016.

Djuric SW, Meanwell NA.

J Med Chem. 2017 Jan 12;60(1):1-3. doi: 10.1021/acs.jmedchem.6b01600. No abstract available.

PMID: 28076959

 

Comparison of cardiovascular risk algorithms in patients with vs without rheumatoid arthritis and the role of C-reactive protein in predicting cardiovascular outcomes in rheumatoid arthritis.

Alemao E, Cawston H, Bourhis F, Al M, Rutten-van Molken M, Liao KP, Solomon DH.

Rheumatology (Oxford). 2017 Jan 12. pii: kew440. doi: 10.1093/rheumatology/kew440. [Epub ahead of print]

PMID: 28087832

 

Discovery of 7-(3-(piperazin-1-yl)phenyl)pyrrolo[2,1-f][1,2,4]triazin-4-amine derivatives as highly potent and selective PI3Kδ inhibitors.

Qin LY, Ruan Z, Cherney RJ, Dhar TG, Neels J, Weigelt CA, Sack JS, Srivastava AS, Cornelius LA, Tino JA, Stefanski K, Gu X, Xie J, Susulic V, Yang X, Yarde-Chinn M, Skala S, Bosnius R, Goldstein C, Davies P, Ruepp S, Salter-Cid L, Bhide RS, Poss MA.

Bioorg Med Chem Lett. 2017 Jan 10. pii: S0960-894X(17)30028-8. doi: 10.1016/j.bmcl.2017.01.016. [Epub ahead of print]

PMID: 28108251

 

Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis.

D'Angelo SP, Larkin J, Sosman JA, Lebbé C, Brady B, Neyns B, Schmidt H, Hassel JC, Hodi FS, Lorigan P, Savage KJ, Miller WH Jr, Mohr P, Marquez-Rodas I, Charles J, Kaatz M, Sznol M, Weber JS, Shoushtari AN, Ruisi M, Jiang J, Wolchok JD.

J Clin Oncol. 2017 Jan 10;35(2):226-235.

PMID: 28056206

 

An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab.

Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M.

AAPS J. 2017 Jan 9. doi: 10.1208/s12248-016-0033-9. [Epub ahead of print]

PMID: 28070715

 

Population Pharmacokinetic Analysis of Daclatasvir in Subjects with Chronic Hepatitis C Virus Infection.

Chan P, Li H, Zhu L, Bifano M, Eley T, Osawa M, Ueno T, Hughes E, Bertz R, Garimella T, AbuTarif M.

Clin Pharmacokinet. 2017 Jan 9. doi: 10.1007/s40262-016-0504-2. [Epub ahead of print]

PMID: 28066880

 

The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease.

Young J, Weis N, Hofer H, Irving W, Weiland O, Giostra E, Pascasio JM, Castells L, Prieto M, Postema R, Lefevre C, Evans D, Bucher HC, Calleja JL.

BMC Infect Dis. 2017 Jan 7;17(1):45. doi: 10.1186/s12879-016-2106-x.

PMID: 28061762

 

A novel reagent significantly improved assay robustness in imaged capillary isoelectric focusing.

Zhang X, Voronov S, Mussa N, Li Z.

Anal Biochem. 2017 Jan 6;521:1-7. doi: 10.1016/j.ab.2016.12.013. [Epub ahead of print]

PMID: 28065577

 

The role of chromatographic and chiroptical spectroscopic techniques and methodologies in support of drug discovery for atropisomeric drug inhibitors of Bruton's tyrosine kinase.

Dai J, Wang C, Traeger SC, Discenza L, Obermeier MT, Tymiak AA, Zhang Y.

J Chromatogr A. 2017 Jan 6. pii: S0021-9673(17)30051-1. doi: 10.1016/j.chroma.2017.01.016. [Epub ahead of print]

PMID: 28131592

 

Effective Combination of Innate and Adaptive Immunotherapeutic Approaches in a Mouse Melanoma Model.

Rakhmilevich AL, Felder M, Lever L, Slowinski J, Rasmussen K, Hoefges A, Van De Voort TJ, Loibner H, Korman AJ, Gillies SD, Sondel PM.

J Immunol. 2017 Jan 6. pii: 1601255. doi: 10.4049/jimmunol.1601255. [Epub ahead of print]

PMID: 28062694

 

Control strategies for drug product continuous direct compression - state of control, product collection strategies, and startup/shutdown operations for the production of clinical trial materials and commercial products.

Almaya A, De Belder L, Meyer R, Nagapudi K, Lin HH, Leavesley I, Jayanth J, Bajwa G, DiNunzio J, Tantuccio A, Blackwood D, Abebe A.

J Pharm Sci. 2017 Jan 6. pii: S0022-3549(16)41939-8. doi: 10.1016/j.xphs.2016.12.014. [Epub ahead of print]

PMID: 28069357

 

Antibodies Targeting Closely Adjacent or Minimally Overlapping Epitopes Can Displace One Another.

Abdiche YN, Yeung AY, Ni I, Stone D, Miles A, Morishige W, Rossi A, Strop P.

PLoS One. 2017 Jan 6;12(1):e0169535. doi: 10.1371/journal.pone.0169535.

PMID: 28060885

 

Using Health Care Claims Data to Assess the Prevalence of Hodgkin Lymphoma and Relapsed or Refractory Hodgkin Lymphoma in the United States.

Lin J, Siegartel LR, Lingohr-Smith M, Menges B, Makenbaeva D.

Clin Ther. 2017 Jan 5. pii: S0149-2918(16)30923-7. doi: 10.1016/j.clinthera.2016.12.010. [Epub ahead of print]

PMID: 28065438

 

Blockade of protease-activated receptor-4 (PAR4) provides robust antithrombotic activity with low bleeding.

Wong PC, Seiffert D, Bird JE, Watson CA, Bostwick JS, Giancarli M, Allegretto N, Hua J, Harden D, Guay J, Callejo M, Miller MM, Lawrence RM, Banville J, Guy J, Maxwell BD, Priestley ES, Marinier A, Wexler RR, Bouvier M, Gordon DA, Schumacher WA, Yang J.

Sci Transl Med. 2017 Jan 4;9(371). pii: eaaf5294. doi: 10.1126/scitranslmed.aaf5294.

PMID: 28053157

 

Role of Fc-FcγR interactions in the antitumor activity of therapeutic antibodies.

Barnhart BC, Quigley M.

Immunol Cell Biol. 2017 Jan 3. doi: 10.1038/icb.2016.121. [Epub ahead of print] Review.

PMID: 27974746

 

Kinesiophobia and physical therapy-related pain in musculoskeletal pain: A national multicenter cohort study on patients and their general physicians.

Perrot S, Trouvin AP, Rondeau V, Chartier I, Arnaud R, Milon JY, Pouchain D.

Joint Bone Spine. 2017 Jan 3. pii: S1297-319X(16)30251-2. doi: 10.1016/j.jbspin.2016.12.014. [Epub ahead of print]

PMID: 28062380

 

Nickel-Catalyzed Barton Decarboxylation and Giese Reactions: A Practical Take on Classic Transforms.

Qin T, Malins LR, Edwards JT, Merchant RR, Novak AJ, Zhong JZ, Mills RB, Yan M, Yuan C, Eastgate MD, Baran PS.

Angew Chem Int Ed Engl. 2017 Jan 2;56(1):260-265. doi: 10.1002/anie.201609662.

PMID: 27981703

 

Copper-Catalyzed Bromination of C(sp₃ )-H Bonds Distal to Functional Groups.

Liu T, Myers MC, Yu JQ.

Angew Chem Int Ed Engl. 2017 Jan 2;56(1):306-309. doi: 10.1002/anie.201608210.

PMID: 27897345

 

Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform.

Liu R, Hoffpauir B, Chilewski SD, Gamberdella J, Kavita U, Duo J, Gleason C, Zhang Y, Pillutla R, DeSilva B, Hamuro L.

AAPS J. 2017 Jan;19(1):82-91. doi: 10.1208/s12248-016-0006-z.

PMID: 27796911

 

Further Evaluation of Covariate Analysis using Empirical Bayes Estimates in Population Pharmacokinetics: the Perception of Shrinkage and Likelihood Ratio Test.

Xu XS, Yuan M, Yang H, Feng Y, Xu J, Pinheiro J.

AAPS J. 2017 Jan;19(1):264-273. doi: 10.1208/s12248-016-0001-4.

PMID: 27761720

 

Particle Characterization for a Protein Drug Product Stored in Pre-Filled Syringes Using Micro-Flow Imaging, Archimedes, and Quartz Crystal Microbalance with Dissipation.

Zheng S, Puri A, Li J, Jaiswal A, Adams M.

AAPS J. 2017 Jan;19(1):110-116. doi: 10.1208/s12248-016-9983-1.

PMID: 27620008

 

Investigating the Degradation Behaviors of a Therapeutic Monoclonal Antibody Associated with pH and Buffer Species.

Zheng S, Qiu D, Adams M, Li J, Mantri RV, Gandhi R.

AAPS PharmSciTech. 2017 Jan 1;18(1):42-48. doi: 10.1208/s12249-015-0403-0.

PMID: 26340951

 

Efficacy and Safety Outcomes of Extended Criteria Donor Kidneys by Subtype: Subgroup Analysis of BENEFIT-EXT at 7 Years After Transplant.

Florman S, Becker T, Bresnahan B, Chevaile-Ramos A, Carvalho D, Grannas G, Muehlbacher F, O'Connell PJ, Meier-Kriesche HU, Larsen CP.

Am J Transplant. 2017 Jan;17(1):180-190. doi: 10.1111/ajt.13886.

PMID: 27232116

 

Differential mobility spectrometry combined with multiple ion monitoring for bioanalysis of disulfide-bonded peptides with inefficient collision-induced dissociation fragmentation.

Xia YQ, Ciccimaro E, Zheng N, Zhu M.

Bioanalysis. 2017 Jan;9(2):183-192.

PMID: 27960545

 

Characterization of labeled reagents in ligand-binding assays by a surface plasmon resonance biosensor.

Duo J, Bruno J, Piccoli S, DeSilva B, Zhang YJ.

Bioanalysis. 2017 Jan;9(2):193-207.

PMID: 27960543

 

Impact of Warfarin Persistence on Health-Care Utilization and Costs Among Patients With Atrial Fibrillation Managed in Anticoagulation Clinics in the United States.

Deitelzweig SB, Evans M, Trocio J, Gupta K, Lingohr-Smith M, Menges B, Lin J.

Clin Appl Thromb Hemost. 2017 Jan 1:1076029616685427. doi: 10.1177/1076029616685427. [Epub ahead of print]

PMID: 28135822

 

Value of Sustained Virologic Response in Patients with Hepatitis C as a Function of Time to Progression of End-Stage Liver Disease.

Ward T, Gordon J, Jones B, Bennett H, Webster S, Kalsekar A, Yuan Y, Brenner M, McEwan P.

Clin Drug Investig. 2017 Jan;37(1):61-70. doi: 10.1007/s40261-016-0458-z.

PMID: 27587071

 

Improving the tools of clinical pharmacology: Goals for 2017 and beyond.

Zineh I, Abernethy D, Hop C, Bello A, McClellan MB, Daniel GW, Romine MH.

Clin Pharmacol Ther. 2017 Jan;101(1):22-24. doi: 10.1002/cpt.530.

PMID: 27727433

 

Quantitative Systems Pharmacology: A Case for Disease Models.

Musante CJ, Ramanujan S, Schmidt BJ, Ghobrial OG, Lu J, Heatherington AC.

Clin Pharmacol Ther. 2017 Jan;101(1):24-27. doi: 10.1002/cpt.528.

PMID: 27709613

 

Model-Based Population Pharmacokinetic Analysis of Nivolumab in Patients With Solid Tumors.

Bajaj G, Wang X, Agrawal S, Gupta M, Roy A, Feng Y.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):58-66. doi: 10.1002/psp4.12143.

PMID: 28019091

 

Quantitative Characterization of the Exposure-Response Relationship for Cancer Immunotherapy: A Case Study of Nivolumab in Patients With Advanced Melanoma.

Wang X, Feng Y, Bajaj G, Gupta M, Agrawal S, Yang A, Park JS, Lestini B, Roy A.

CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):40-48. doi: 10.1002/psp4.12133.

PMID: 28019090

 

Inhibition of Intestinal OATP2B1 by the Calcium Receptor Antagonist Ronacaleret Results in a Significant Drug-Drug Interaction by Causing a 2-Fold Decrease in Exposure of Rosuvastatin.

Johnson M, Patel D, Matheny C, Ho M, Chen L, Ellens H.

Drug Metab Dispos. 2017 Jan;45(1):27-34.

PMID: 27737931

 

A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants.

Halvorsen S, Ghanima W, Fride Tvete I, Hoxmark C, Falck P, Solli O, Jonasson C.

Eur Heart J Cardiovasc Pharmacother. 2017 Jan;3(1):28-36. doi: 10.1093/ehjcvp/pvw031.

PMID: 27680880

 

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results.

Margolskee A, Darwich AS, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Laplanche L, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B.

Eur J Pharm Sci. 2017 Jan 1;96:610-625. doi: 10.1016/j.ejps.2016.10.036.

PMID: 27816631

 

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.

Darwich AS, Margolskee A, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B.

Eur J Pharm Sci. 2017 Jan 1;96:626-642. doi: 10.1016/j.ejps.2016.09.037.

PMID: 27693299

 

In Vitro Metabolite Formation in Human Hepatocytes and Cardiomyocytes and Metabolism and Tissue Distribution in Monkeys of the 2'-C-Methylguanosine Prodrug BMS-986094.

Li W, Trouba KJ, Ma L, Kwagh J, Storck C, Zhu Y, Flint O, Humphreys WG, Wang J, Liu A, Wang B, Graziano MJ, Davies MH, Sanderson TP.

Int J Toxicol. 2017 Jan 1:1091581816683642. doi: 10.1177/1091581816683642. [Epub ahead of print]

PMID: 28056568

 

Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer.

Beer TM, Kwon ED, Drake CG, Fizazi K, Logothetis C, Gravis G, Ganju V, Polikoff J, Saad F, Humanski P, Piulats JM, Gonzalez Mella P, Ng SS, Jaeger D, Parnis FX, Franke FA, Puente J, Carvajal R, Sengeløv L, McHenry MB, Varma A, van den Eertwegh AJ, Gerritsen W.

J Clin Oncol. 2017 Jan;35(1):40-47.

PMID: 28034081

 

Interleukin (IL) 31 induces in cynomolgus monkeys a rapid and intense itch response that can be inhibited by an IL-31 neutralizing antibody.

Lewis KE, Holdren MS, Maurer MF, Underwood S, Meengs B, Julien SH, Byrnes-Blake KA, Freeman JA, Bukowski TR, Wolf AC, Hamacher NB, Rixon MW, Dillon SR.

J Eur Acad Dermatol Venereol. 2017 Jan;31(1):142-150. doi: 10.1111/jdv.13794.

PMID: 27501029

 

Real-world treatment patterns and clinical outcomes of HCV treatment-naive patients in China: an interim analysis from the CCgenos study.

Rao HY, Li H, Chen H, Shang J, Xie Q, Gao ZL, Li J, Sun Y, Jiang J, Wang L, Zhao L, Zhang L, Yang W, Niu J, Gong Z, Gong G, Yang R, Lee MH, Wei L.

J Gastroenterol Hepatol. 2017 Jan;32(1):244-252. doi: 10.1111/jgh.13467.

PMID: 27289083

 

The synthesis of [1-₁₄ C]2-(1H-tetrazol-5-yl)acetic acid.

Maxwell BD, Tran SB.

J Labelled Comp Radiopharm. 2017 Jan;60(1):49-54. doi: 10.1002/jlcr.3472.

PMID: 27966233

 

Impact of apixaban vs low molecular weight heparin/vitamin k antagonist on hospital resource use in patients with venous thromboembolism.

Browne C, Lanitis T, Hamilton M, Li X, Horbyluk R, Mardekian J, Kongnakorn T, Cohen A.

J Med Econ. 2017 Jan;20(1):98-106.

PMID: 27822962

 

Long-Term Follow-Up of Children Treated With Peginterferon and Ribavirin for Hepatitis C Virus Infection.

Haber B, Alonso E, Pedreira A, Rodriguez-Baez N, Ciocca M, Lacaille F, Lang T, Gonzalez T, Goodman Z, Yang Z, Jackson B, Noviello S, Albrecht JK.

J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):89-94. doi: 10.1097/MPG.0000000000001239.

PMID: 27111344

 

Application of In-line Focused Beam Reflectance Measurement to Brivanib Alaninate Wet Granulation Process to Enable Scale-up and Attribute-based Monitoring and Control Strategies.

Narang AS, Stevens T, Macias K, Paruchuri S, Gao Z, Badawy S.

J Pharm Sci. 2017 Jan;106(1):224-233. doi: 10.1016/j.xphs.2016.08.025.

PMID: 27771049

 

Assessment of Tablet Surface Hardness by Laser Ablation and Its Correlation With the Erosion Tendency of Core Tablets.

Narang AS, Breckenridge L, Guo H, Wang J, Wolf AA, Desai D, Varia S, Badawy S.

J Pharm Sci. 2017 Jan;106(1):200-207. doi: 10.1016/j.xphs.2016.08.008.

PMID: 27686683

 

Disrupted Murine Gut-to-Human Liver Signaling Alters Bile Acid Homeostasis in Humanized Mouse Liver Models.

Chow EC, Quach HP, Zhang Y, Wang JZ, Evans DC, Li AP, Silva J, Tirona RG, Lai Y, Pang KS.

J Pharmacol Exp Ther. 2017 Jan;360(1):174-191.

PMID: 27789682

 

PD-L1 Expression by Two Complementary Diagnostic Assays and mRNA In Situ Hybridization in Small Cell Lung Cancer.

Yu H, Batenchuk C, Badzio A, Boyle TA, Czapiewski P, Chan DC, Lu X, Gao D, Ellison K, Kowalewski AA, Rivard CJ, Dziadziuszko R, Zhou C, Hussein M, Richards D, Wilks S, Monte M, Edenfield W, Goldschmidt J, Page R, Ulrich B, Waterhouse D, Close S, Jassem J, Kulig K, Hirsch FR.

J Thorac Oncol. 2017 Jan;12(1):110-120. doi: 10.1016/j.jtho.2016.09.002.

PMID: 27639678

 

Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study.

Hellmann MD, Rizvi NA, Goldman JW, Gettinger SN, Borghaei H, Brahmer JR, Ready NE, Gerber DE, Chow LQ, Juergens RA, Shepherd FA, Laurie SA, Geese WJ, Agrawal S, Young TC, Li X, Antonia SJ.

Lancet Oncol. 2017 Jan;18(1):31-41. doi: 10.1016/S1470-2045(16)30624-6.

PMID: 27932067

 

Development of adsorptive hybrid filters to enable two-step purification of biologics.

Singh N, Arunkumar A, Peck M, Voloshin AM, Moreno AM, Tan Z, Hester J, Borys MC, Li ZJ.

MAbs. 2017 Feb/Mar;9(2):350-363. doi: 10.1080/19420862.2016.1267091.

PMID: 27929735

 

HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib.

Press MF, Ellis CE, Gagnon RC, Grob TJ, Buyse M, Villalobos I, Liang Z, Wu S, Bang YJ, Qin SK, Chung HC, Xu J, Park JO, Jeziorski K, Afenjar K, Ma Y, Estrada MC, Robinson DM, Scherer SJ, Sauter G, Hecht JR, Slamon DJ.

Mol Cancer Ther. 2017 Jan;16(1):228-238. doi: 10.1158/1535-7163.MCT-15-0887.

PMID: 27811012

 

Transiently increased glutamate cycling in rat PFC is associated with rapid onset of antidepressant-like effects.

Chowdhury GM, Zhang J, Thomas M, Banasr M, Ma X, Pittman B, Bristow L, Schaeffer E, Duman RS, Rothman DL, Behar KL, Sanacora G.

Mol Psychiatry. 2017 Jan;22(1):120-126. doi: 10.1038/mp.2016.34.

PMID: 27067013

 

Clinical Pharmacology Studies in Critically Ill Children.

Thakkar N, Salerno S, Hornik CP, Gonzalez D.

Pharm Res. 2017 Jan;34(1):7-24. doi: 10.1007/s11095-016-2033-y. Review.

PMID: 27585904

 

Principles for Assessing Adversity in Toxicologic Clinical Pathology.

Ramaiah L, Tomlinson L, Tripathi NK, Cregar LC, Vitsky A, von Beust B, Barlow VG, Reagan WJ, Ennulat D.

Toxicol Pathol. 2017 Jan 1:192623316681646. doi: 10.1177/0192623316681646. [Epub ahead of print]

PMID: 28056663

 

Interpreting and Integrating Clinical and Anatomic Pathology Results.

Ramaiah L, Hinrichs MJ, Skuba EV, Iverson WO, Ennulat D.

Toxicol Pathol. 2017 Jan;45(1):223-237. doi: 10.1177/0192623316677068.

PMID: 27879439

The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.

Mariette X, Alten R, Nüßlein HG, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M.

Joint Bone Spine. 2016 Dec 30. pii: S1297-319X(16)30210-X. doi: 10.1016/j.jbspin.2016.10.011. [Epub ahead of print]

PMID: 28043761

 

Designer vaccine nanodiscs for personalized cancer immunotherapy.

Kuai R, Ochyl LJ, Bahjat KS, Schwendeman A, Moon JJ.

Nat Mater. 2016 Dec 26. doi: 10.1038/nmat4822. [Epub ahead of print]

PMID: 28024156

 

Real-World Experience With Daclatasvir Plus Sofosbuvir ± Ribavirin for Post-Liver Transplant HCV Recurrence and Severe Liver Disease.

Herzer K, Welzel TM, Spengler U, Hinrichsen H, Klinker H, Berg T, Ferenci P, Peck-Radosavljevic M, Inderson A, Zhao Y, Jimenez-Exposito MJ, Zeuzem S.

Transpl Int. 2016 Dec 24. doi: 10.1111/tri.12910. [Epub ahead of print]

PMID: 28012215

 

Effect of minor populations of NS5A and NS5B resistance-associated variants on HCV genotype-3 response to daclatasvir plus sofosbuvir, with or without ribavirin.

McPhee F, Hernandez D, Zhou N.

Antivir Ther. 2016 Dec 23. doi: 10.3851/IMP3120. [Epub ahead of print]

PMID: 28008868

 

Effects of aripiprazole and haloperidol on neural activation during a simple motor task in healthy individuals: A functional MRI study.

Goozee R, O'Daly O, Handley R, Reis Marques T, Taylor H, McQueen G, Hubbard K, Pariante C, Mondelli V, Reinders AA, Dazzan P.

Hum Brain Mapp. 2016 Dec 23. doi: 10.1002/hbm.23485. [Epub ahead of print]

PMID: 28009070

 

Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy.

Restelli U, Alberti A, Lazzarin A, Bonfanti M, Nappi C, Croce D.

Eur J Health Econ. 2016 Dec 22. doi: 10.1007/s10198-016-0865-3. [Epub ahead of print]

PMID: 28008546

 

Asymmetric Hydroboration Approach to the Scalable Synthesis of ((1R,3S)-1-Amino-3-((R)-6-hexyl-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol (BMS-986104) as a Potent S1P₁ Receptor Modulator.

Yang MG, Xiao Z, Dhar TG, Xiao HY, Gilmore JL, Marcoux D, Xie JH, McIntyre KW, Taylor TL, Borowski V, Heimrich E, Li YW, Feng J, Fernandes A, Yang Z, Balimane P, Marino AM, Cornelius G, Warrack BM, Mathur A, Wu DR, Li P, Gupta A, Pragalathan B, Shen DR, Cvijic ME, Lehman-McKeeman LD, Salter-Cid L, Barrish JC, Carter PH, Dyckman AJ.

J Med Chem. 2016 Dec 22;59(24):11138-11147. doi: 10.1021/acs.jmedchem.6b01433.

PMID: 28002964

 

Design and Synthesis of a New Series of 4-Heteroarylamino-1'-azaspiro[oxazole-5,3'-bicyclo[2.2.2]octanes as α7 Nicotinic Receptor Agonists. 1. Development of Pharmacophore and Early Structure-Activity Relationship.

Cook J, Zusi FC, McDonald IM, King D, Hill MD, Iwuagwu C, Mate RA, Fang H, Zhao R, Wang B, Cutrone J, Ma B, Gao Q, Knox RJ, Matchett M, Gallagher L, Ferrante M, Post-Munson D, Molski T, Easton A, Miller R, Jones K, Digavalli S, Healy F, Lentz K, Benitex Y, Clarke W, Natale J, Siuciak JA, Lodge N, Zaczek R, Denton R, Morgan D, Bristow LJ, Macor JE, Olson RE.

J Med Chem. 2016 Dec 22;59(24):11171-11181. doi: 10.1021/acs.jmedchem.6b01506.

PMID: 27958732

 

Discovery of Indazoles as Potent, Orally Active Dual Neurokinin 1 Receptor Antagonists and Serotonin Transporter Inhibitors for the Treatment of Depression.

Degnan AP, Tora GO, Huang H, Conlon DA, Davis CD, Hanumegowda UM, Hou X, Hsiao Y, Hu J, Krause R, Li YW, Newton AE, Pieschl RL, Raybon J, Rosner T, Sun JH, Taber MT, Taylor SJ, Wong MK, Zhang H, Lodge NJ, Bronson JJ, Macor JE, Gillman KW.

ACS Chem Neurosci. 2016 Dec 21;7(12):1635-1640. doi: 10.1021/acschemneuro.6b00337.

PMID: 27744678

 

Evaluation of automated Wes system as an analytical and characterization tool to support monoclonal antibody drug product development.

Wang J, Valdez A, Chen Y.

J Pharm Biomed Anal. 2016 Dec 21. pii: S0731-7085(16)30669-0. doi: 10.1016/j.jpba.2016.12.024. [Epub ahead of print]

PMID: 28069351

 

Phase 2 Placebo-Controlled, Double-Blind Trial of Dasatinib Added to Gemcitabine for Patients with Locally-Advanced Pancreatic Cancer.

Evans TR, Van Cutsem E, Moore MJ, Bazin IS, Rosemurgy A, Bodoky G, Deplanque G, Harrison M, Melichar B, Pezet D, Elekes A, Rock E, Lin C, Strauss L, O'Dwyer PJ.

Ann Oncol. 2016 Dec 19. pii: mdw607. doi: 10.1093/annonc/mdw607. [Epub ahead of print]

PMID: 27998964

 

Revised Reply to Letter to the Editor with regards to manuscript AR-15-1750.R1.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Dec 19. doi: 10.1002/art.40021. [Epub ahead of print] No abstract available.

PMID: 27992708

 

Systematic interpolation method predicts protein chromatographic elution with salt gradients, pH gradients and combined salt/pH gradients.

Creasy A, Barker G, Carta G.

Biotechnol J. 2016 Dec 19. doi: 10.1002/biot.201600636. [Epub ahead of print]

PMID: 27992113

 

Drug-Protein Adducts: Chemistry, Mechanisms of Toxicity, and Methods of Characterization.

Gan J, Zhang H, Humphreys WG.

Chem Res Toxicol. 2016 Dec 19;29(12):2040-2057.

PMID: 27989144

 

Functionalized triazines as potent HCV entry inhibitors.

Mull ES, Sun LQ, Zhao Q, Eggers B, Pokornowski K, Zhai G, Rajamani R, Jenkins S, Kramer M, Wang YK, Fang H, Tenney D, Baldick CJ, Cockett MI, Meanwell NA, Scola PM.

Bioorg Med Chem Lett. 2016 Dec 18. pii: S0960-894X(16)31304-X. doi: 10.1016/j.bmcl.2016.12.038. [Epub ahead of print]

PMID: 28089701

 

Difluorocyclobutylacetylenes as positive allosteric modulators of mGluR5 with reduced bioactivation potential.

Degnan AP, Maxwell D, Balakrishnan A, Brown JM, Easton A, Gulianello M, Hanumegowda U, Hill-Drzewi M, Miller R, Santone KS, Senapati A, Shields EE, Sivarao DV, Westphal R, Whiterock VJ, Zhuo X, Bronson JJ, Macor JE.

Bioorg Med Chem Lett. 2016 Dec 15;26(24):5871-5876. doi: 10.1016/j.bmcl.2016.11.014.

PMID: 27856084

 

Characterization of TAP Ambr 250 disposable bioreactors, as a reliable scale-down model for biologics process development.

Xu P, Clark C, Ryder T, Sparks C, Zhou J, Wang M, Russell R, Scott C.

Biotechnol Prog. 2016 Dec 15. doi: 10.1002/btpr.2417. [Epub ahead of print]

PMID: 27977912

 

Structure of CC chemokine receptor 2 with orthosteric and allosteric antagonists.

Zheng Y, Qin L, Zacarías NV, de Vries H, Han GW, Gustavsson M, Dabros M, Zhao C, Cherney RJ, Carter P, Stamos D, Abagyan R, Cherezov V, Stevens RC, IJzerman AP, Heitman LH, Tebben A, Kufareva I, Handel TM.

Nature. 2016 Dec 15;540(7633):458-461. doi: 10.1038/nature20605.

PMID: 27926736

 

Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process.

Pandey P, Levins C, Pafiakis S, Zacour B, Bindra DS, Trinh J, Buckley D, Gour S, Sharif S, Stamato H.

Pharm Dev Technol. 2016 Dec 15:1-9. [Epub ahead of print]

PMID: 27879156

 

Microbiota metabolite short-chain fatty acid acetate promotes intestinal IgA response to microbiota which is mediated by GPR43.

Wu W, Sun M, Chen F, Cao AT, Liu H, Zhao Y, Huang X, Xiao Y, Yao S, Zhao Q, Liu Z, Cong Y.

Mucosal Immunol. 2016 Dec 14. doi: 10.1038/mi.2016.114. [Epub ahead of print]

PMID: 27966553

 

Real-World Assessment of Renal and Bone Safety among Patients with HIV Infection Exposed to Tenofovir Disoproxil Fumarate-Containing Single-Tablet Regimens.

Nkhoma ET, Rosenblatt L, Myers J, Villasis-Keever A, Coumbis J.

PLoS One. 2016 Dec 12;11(12):e0166982. doi: 10.1371/journal.pone.0166982.

PMID: 27941989

  

Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study).

Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M.

Liver Int. 2016 Dec 10. doi: 10.1111/liv.13335. [Epub ahead of print]

PMID: 27943563

 

The cellular kinetics of lung alveolar epithelial cells and its relationship with lung tissue repair after acute lung injury.

Zeng L, Yang XT, Li HS, Li Y, Yang C, Gu W, Zhou YH, Du J, Wang HY, Sun JH, Wen DL, Jiang JX.

Respir Res. 2016 Dec 7;17(1):164.

PMID: 27923370

 

 Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OA, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI.; study team..

Antivir Ther. 2016 Dec 6. doi: 10.3851/IMP3112. [Epub ahead of print]

PMID: 27922453

 

A carbon dioxide stripping model for mammalian cell culture in manufacturing scale bioreactors.

Xing Z, Lewis AM, Borys MC, Li ZJ.

Biotechnol Bioeng. 2016 Dec 6. doi: 10.1002/bit.26232. [Epub ahead of print]

PMID: 27922179

 

John Staniforth-An appreciation: The non-conformist nonconformist.

Tobyn M, Price R.

Int J Pharm. 2016 Dec 5;514(2):333-334. doi: 10.1016/j.ijpharm.2016.10.028. No abstract available.

PMID: 27780744

 

Development of aqueous dispersions of Coenzyme Q₁₀ for pulmonary delivery and the dynamics of active vibrating-mesh aerosolization.

Carvalho TC, McCook JP, Narain NR, McConville JT.

Int J Pharm. 2016 Dec 5;514(2):407-419. doi: 10.1016/j.ijpharm.2016.10.011.

PMID: 27732894

 

Pre-absorption physicochemical compatibility assessment of 8-drug metabolic cocktail.

Tye CK, Wang Z, Dockens RC, Vakkalagadda B, Wang C, Zhang Y, Su CC, Hageman MJ.

Int J Pharm. 2016 Dec 5;514(2):364-373. doi: 10.1016/j.ijpharm.2016.06.028.

PMID: 27291974

 

Use of similarity scoring in the development of oral solid dosage forms.

Ferreira AP, Olusanmi D, Sprockel O, Abebe A, Nikfar F, Tobyn M.

Int J Pharm. 2016 Dec 5;514(2):335-340. doi: 10.1016/j.ijpharm.2015.09.046.

PMID: 26423176

 

Discrepancies in column parameters presented in hydrophobic subtraction model manuscripts.

Shackman JG.

J Chromatogr A. 2016 Dec 2;1475:116-118. doi: 10.1016/j.chroma.2016.11.006. No abstract available.

PMID: 27842900

 

Development of 4-Heteroarylamino-1'-azaspiro[oxazole-5,3'-bicyclo[2.2.2]octanes] as α7 Nicotinic Receptor Agonists.

Hill MD, Fang H, King HD, Iwuagwu CI, McDonald IM, Cook J, Zusi FC, Mate RA, Knox RJ, Post-Munson D, Easton A, Miller R, Lentz K, Clarke W, Benitex Y, Lodge N, Zaczek R, Denton R, Morgan D, Bristow L, Macor JE, Olson R.

ACS Med Chem Lett. 2016 Dec 1;8(1):133-137. doi: 10.1021/acsmedchemlett.6b00471.

PMID: 28105289

 

Reasons for non-intensification of treatment in people with type 2 diabetes receiving oral monotherapy: Outcomes from the prospective DIAttitude study.

Balkau B, Halimi S, Blickle JF, Vergès B, Avignon A, Attali C, Chartier I, Amelineau E.

Ann Endocrinol (Paris). 2016 Dec;77(6):649-657. doi: 10.1016/j.ando.2016.03.001.

PMID: 27646493

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R.

Bioanalysis. 2016 Dec;8(23):2475-2496.

PMID: 27855512

 

UHPLC-MS/MS bioanalysis of urinary DHEA, cortisone and their hydroxylated metabolites as potential biomarkers for CYP3A-mediated drug-drug interactions.

Zheng N, Christopher LJ, Ma X, Ji QC, Buzescu A, Kandoussi H, Garonzik SM, LaCreta F, Aubry AF, Arnold ME, Zeng J.

Bioanalysis. 2016 Dec;8(23):2429-2443.

PMID: 27855510

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

Song A, Lee A, Garofolo F, Kaur S, Duggan J, Evans C, Palandra J, Donato LD, Xu K, Bauer R, Bustard M, Chen L, Cocea L, Croft S, Galliccia F, Haidar S, Hughes N, Ishii-Watabe A, Islam R, Jones B, Kadavil J, Krantz C, Lima Santos GM, Olah T, Pedras-Vasconcelos J, Staelens L, Saito Y, Savoie N, Scheibner K, Spitz S, Tampal N, Thomas E, Vinter S, Wakelin-Smith J, Welink J, Zeng J, Zhou S.

Bioanalysis. 2016 Dec;8(23):2457-2474.

PMID: 27855509

 

A simple, fast, sensitive and robust LC-MS/MS bioanalytical assay for evaluating 7α-hydroxy-4-cholesten-3-one biomarker in a clinical program.

Yuan L, Luo Y, Kandoussi H, Ji QC.

Bioanalysis. 2016 Dec;8(23):2445-2455.

PMID: 27855505

 

Robust Ki67 detection in human blood by flow cytometry for clinical studies.

Sun Y, Yang K, Bridal T, Ehrhardt AG.

Bioanalysis. 2016 Dec;8(23):2399-2413.

PMID: 27807982

 

Allosteric activation of midazolam CYP3A5 hydroxylase activity by icotinib - Enhancement by ketoconazole.

Zhuang X, Zhang T, Yue S, Wang J, Luo H, Zhang Y, Li Z, Che J, Yang H, Li H, Zhu M, Lu C.

Biochem Pharmacol. 2016 Dec 1;121:67-77. doi: 10.1016/j.bcp.2016.09.012.

PMID: 27666601

 

[2.2.1]-Bicyclic sultams as potent androgen receptor antagonists.

Shan W, Balog A, Nation A, Zhu X, Chen J, Cvijic ME, Geng J, Rizzo CA, Spires T Jr, Attar RM, Obermeier M, Traeger S, Dai J, Zhang Y, Galella M, Trainor G, Vite GD, Gavai AV.

Bioorg Med Chem Lett. 2016 Dec 1;26(23):5707-5711. doi: 10.1016/j.bmcl.2016.10.059.

PMID: 27836399

 

Discovery of furo[2,3-d][1,3]thiazinamines as beta amyloid cleaving enzyme-1 (BACE1) inhibitors.

Wu YJ, Guernon J, Rajamani R, Toyn JH, Ahlijanian MK, Albright CF, Muckelbauer J, Chang C, Camac D, Macor JE, Thompson LA.

Bioorg Med Chem Lett. 2016 Dec 1;26(23):5729-5731. doi: 10.1016/j.bmcl.2016.10.055.

PMID: 27816517

 

Effects of elotuzumab on QT interval and cardiac safety in patients with multiple myeloma.

Passey C, Darbenzio R, Jou YM, Lynch M, Gupta M.

Cancer Chemother Pharmacol. 2016 Dec;78(6):1237-1244.

PMID: 27796540

 

A Systematic Literature Review on the Cost-Effectiveness of Apixaban for Stroke Prevention in Non-valvular Atrial Fibrillation.

Pinyol C, Cepeda JM, Roldan I, Roldan V, Jimenez S, Gonzalez P, Soto J.

Cardiol Ther. 2016 Dec;5(2):171-186.

PMID: 27457613

 

Using Population Pharmacokinetic and Pharmacodynamic Analyses of Entecavir in Pediatric Subjects to Simplify Dosing Recommendations.

Chan P, Mould DR, Tarif MA, Reynolds L, LaCreta F, Bertz R, Bifano M.

Clin Pharmacokinet. 2016 Dec;55(12):1559-1572.

PMID: 27319000

 

Atazanavir and Cardiovascular Risk Among Human Immunodeficiency Virus-Infected Patients: A Systematic Review.

Chow D, Shikuma C, Ritchings C, Guo M, Rosenblatt L.

Infect Dis Ther. 2016 Dec;5(4):473-489. Review.

PMID: 27677263

 

Characterization of NS5A polymorphisms and their impact on response rates in patients with HCV genotype 2 treated with daclatasvir-based regimens.

Zhou N, Han Z, Hartman-Neumann S, DeGray B, Ueland J, Vellucci V, Hernandez D, McPhee F.

J Antimicrob Chemother. 2016 Dec;71(12):3495-3505.

PMID: 27605597

 

Collaborating to improve the use of free-energy and other quantitative methods in drug discovery.

Sherborne B, Shanmugasundaram V, Cheng AC, Christ CD, DesJarlais RL, Duca JS, Lewis RA, Loughney DA, Manas ES, McGaughey GB, Peishoff CE, van Vlijmen H.

J Comput Aided Mol Des. 2016 Dec;30(12):1139-1141. doi: 10.1007/s10822-016-9996-y.

PMID: 28013427

 

Nationwide survey of specialist knowledge on current standard of care (Peg-IFN/RBV) and barriers of care in chronic hepatitis C patients in China.

Wei L, Li J, Yang X, Wang G, Feng B, Hou J, Duan Z, Jia J, Ren H, Niu J, Chen X, Wang FS, Shang J, Bo Q, Li R, Liu Y, Zhuang H.

J Gastroenterol Hepatol. 2016 Dec;31(12):1995-2003. doi: 10.1111/jgh.13399.

PMID: 27043040

 

The syntheses of isotopically labelled CB-1 antagonists for the treatment of obesity.

Tran SB, Maxwell BD, Burrell R, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Dec;59(14):665-672. doi: 10.1002/jlcr.3433.

PMID: 27624665

 

The synthesis and analysis of [phenyl-₁₄ C(U)]BMS-770767 and [₁₃ C₆ ]BMS-770767 for use in discovery biotransformation, human ADME and bioanalytical studies.

Maxwell BD, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Dec;59(14):657-664. doi: 10.1002/jlcr.3428.

PMID: 27460954

 

Literature review of the distribution of hepatitis C virus genotypes across Europe.

Alberti A, Lacoin L, Morais E, Lefevre C, Abogunrin S, Iheanacho I.

J Med Virol. 2016 Dec;88(12):2157-2169. doi: 10.1002/jmv.24573.

PMID: 27171396

 

Resolution and Sensitivity of Inline Focused Beam Reflectance Measurement During Wet Granulation in Pharmaceutically Relevant Particle Size Ranges.

Narang AS, Stevens T, Hubert M, Paruchuri S, Macias K, Bindra D, Gao Z, Badawy S.

J Pharm Sci. 2016 Dec;105(12):3594-3602. doi: 10.1016/j.xphs.2016.09.001.

PMID: 27745886

 

Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry.

Weiss WF 4th, Gabrielson JP, Al-Azzam W, Chen G, Davis DL, Das TK, Hayes DB, Houde D, Singh SK.

J Pharm Sci. 2016 Dec;105(12):3465-3470. doi: 10.1016/j.xphs.2016.09.003.

PMID: 27743675

 

Autoxidation of betulonaldehyde.

Ayers S, Benkovics T, Marshall J, Tan Y.

Planta Med. 2016 Dec;81(S 01):S1-S381. No abstract available.

PMID: 27975757

 

Tackling the burden of the hepatitis C virus in the UK: characterizing and assessing the clinical and economic consequences.

Ward T, Gordon J, Bennett H, Webster S, Sugrue D, Jones B, Brenner M, McEwan P.

Public Health. 2016 Dec;141:42-51. doi: 10.1016/j.puhe.2016.08.002.

PMID: 27932014

 

Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?

Pavlovic M, Garnier J, Durand-Zaleski I; participants of Round Table n(o) 3 of Giens XXXI., Bilbault P, Gaudin AF, Le Jeunne C, Lalaude O, Roze S, de Sahb R, Sapède C.

Therapie. 2016 Dec;71(6):625-632. doi: 10.1016/j.therap.2016.03.004.

PMID: 27639631

 

Evaluation of microRNAs-208 and 133a/b as differential biomarkers of acute cardiac and skeletal muscle toxicity in rats.

Calvano J, Achanzar W, Murphy B, DiPiero J, Hixson C, Parrula C, Burr H, Mangipudy R, Tirmenstein M.

Toxicol Appl Pharmacol. 2016 Dec 1;312:53-60. doi: 10.1016/j.taap.2015.11.015.

PMID: 26627004

 

MicroRNA as biomarkers of mitochondrial toxicity.

Baumgart BR, Gray KL, Woicke J, Bunch RT, Sanderson TP, Van Vleet TR.

Toxicol Appl Pharmacol. 2016 Dec 1;312:26-33. doi: 10.1016/j.taap.2015.10.007.

PMID: 26476301

 

The Cost of Costing Treatments Incorrectly: Errors in the Application of Drug Prices in Economic Evaluation Due to Failing to Account for the Distribution of Patient Weight.

Hatswell AJ, Porter J, Lee D, Hertel N, Latimer NR.

Value Health. 2016 Dec;19(8):1055-1058. doi: 10.1016/j.jval.2016.04.013.

PMID: 27987632

 

A Cost-Effectiveness Analysis of Nivolumab Compared with Ipilimumab for the Treatment of BRAF Wild-Type Advanced Melanoma in Australia.

Bohensky MA, Pasupathi K, Gorelik A, Kim H, Harrison JP, Liew D.

Value Health. 2016 Dec;19(8):1009-1015. doi: 10.1016/j.jval.2016.05.013.

PMID: 27987627

 

Reducing blood volume requirements for clinical pathology testing in toxicologic studies-points to consider.

Poitout-Belissent F, Aulbach A, Tripathi N, Ramaiah L.

Vet Clin Pathol. 2016 Dec;45(4):534-551. doi: 10.1111/vcp.12429.

PMID: 27935623

 

Additive free preparative chiral SFC separations of 2,2-dimethyl-3-aryl-propanoic acids.

Wu DR, Yip SH, Li P, Sun D, Kempson J, Mathur A.

J Pharm Biomed Anal. 2016 Nov 30;131:54-63. doi: 10.1016/j.jpba.2016.08.009.

PMID: 27522108

 

Use of Spray-Dried Dispersions in Early Pharmaceutical Development: Theoretical and Practical Challenges.

Li J, Patel D, Wang G.

AAPS J. 2016 Nov 28. [Epub ahead of print]

PMID: 27896684

 

Population Pharmacokinetics of an Extended-Release Formulation of Exenatide Following Single- and Multiple-Dose Administration.

Cirincione B, Edwards J, Mager DE.

AAPS J. 2016 Nov 28. [Epub ahead of print]

PMID: 27896683

 

Mechanistic Studies and Modeling Reveal the Origin of Differential Inhibition of Gag Polymorphic Viruses by HIV-1 Maturation Inhibitors.

Lin Z, Cantone J, Lu H, Nowicka-Sans B, Protack T, Yuan T, Yang H, Liu Z, Drexler D, Regueiro-Ren A, Meanwell NA, Cockett M, Krystal M, Lataillade M, Dicker IB.

PLoS Pathog. 2016 Nov 28;12(11):e1005990. doi: 10.1371/journal.ppat.1005990.

PMID: 27893830

 

Surface induced three-peak elution behavior of a monoclonal antibody during cation exchange chromatography.

Guo J, Creasy AD, Barker G, Carta G.

J Chromatogr A. 2016 Nov 25;1474:85-94. doi: 10.1016/j.chroma.2016.10.061.

PMID: 27802880

 

Allogeneic human mesenchymal stem cells in patients with idiopathic pulmonary fibrosis via intravenous delivery (AETHER): a phase I, safety, clinical trial.

Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, Difede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM.

Chest. 2016 Nov 24. pii: S0012-3692(16)62462-5. doi: 10.1016/j.chest.2016.10.061. [Epub ahead of print]

PMID: 27890713

 

A novel liquid chromatography tandem mass spectrometry method for the estimation of bilirubin glucuronides and its application to in vitro enzyme assays.

Putluru SP, Matta MK, Ahire D, Subramanian M, Sinz M, Mandlekar S.

Drug Metab Lett. 2016 Nov 24. [Epub ahead of print]

PMID: 27908259

 

Safety and Efficacy Outcomes 3 Years After Switching to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: Results From a Phase 2 Randomized Trial.

Grinyó JM, Del Carmen Rial M, Alberu J, Steinberg SM, Manfro RC, Nainan G, Vincenti F, Jones-Burton C, Kamar N.

Am J Kidney Dis. 2016 Nov 23. pii: S0272-6386(16)30572-8. doi: 10.1053/j.ajkd.2016.09.021. [Epub ahead of print]

PMID: 27889299

Synthesis of unlabelled and stable-isotope-labelled glucuronide metabolites of dapagliflozin and synthesis of stable-isotope-labelled dapagliflozin.

Cao K, Brailsford JA, Yao M, Caceres-Cortes J, Espina R, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Nov 21. doi: 10.1002/jlcr.3484. [Epub ahead of print]

PMID: 27868223

 

A comparison of the variance estimation methods for heteroscedastic nonlinear models.

Sidik K, Jonkman JN.

Stat Med. 2016 Nov 20;35(26):4856-4874. doi: 10.1002/sim.7024.

PMID: 27383279

 

Readmission Risk in Chronic Obstructive Pulmonary Disease Patients: Comparative Study of Nebulized β₂-Agonists.

Bollu V, Guérin A, Gauthier G, Hiscock R, Wu EQ.

Drugs Real World Outcomes. 2016 Nov 18. [Epub ahead of print]

PMID: 27864792

 

Investigation of the "true" extraction recovery of analytes from multiple types of tissues and its impact on tissue bioanalysis using two model compounds.

Yuan L, Ma L, Dillon L, Fancher RM, Sun H, Zhu M, Lehman-McKeeman L, Aubry AF, Ji QC.

Anal Chim Acta. 2016 Nov 16;945:57-66. doi: 10.1016/j.aca.2016.09.039.

PMID: 27968716

 

COMBINED TREATMENT WITH SAXAGLIPTIN PLUS DAPAGLIFLOZIN REDUCES INSULIN LEVELS BY INCREASED INSULIN CLEARANCE AND IMPROVES β-CELL FUNCTION.

Ekholm E, Hansen L, Johnsson E, Iqbal N, Carlsson B, Chen H, Hirshberg B.

Endocr Pract. 2016 Nov 16. [Epub ahead of print]

PMID: 27849380

 

Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.

Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Exposito MJ, Zeuzem S.

Antivir Ther. 2016 Nov 15. doi: 10.3851/IMP3108. [Epub ahead of print]

PMID: 27845298

 

Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma.

Choueiri TK, Fishman MN, Escudier B, McDermott DF, Drake CG, Kluger H, Stadler WM, Perez-Gracia JL, McNeel DG, Curti B, Harrison MR, Plimack ER, Appleman L, Fong L, Albiges L, Cohen L, Young TC, Chasalow SD, Ross-Macdonald P, Srivastava S, Jure-Kunkel M, Kurland JF, Simon JS, Sznol M.

Clin Cancer Res. 2016 Nov 15;22(22):5461-5471. doi: 10.1158/1078-0432.CCR-15-2839.

PMID: 27169994

 

 Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study.

Iida S, Nagai H, Kinoshita G, Miyoshi M, Robbins M, Pandya D, Bleickardt E, Chou T.

Int J Hematol. 2016 Nov 15. [Epub ahead of print]

PMID: 27848182

 

Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy.

Agrawal S, Feng Y, Roy A, Kollia G, Lestini B.

J Immunother Cancer. 2016 Nov 15;4:72.

PMID: 27879974

 

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma.

Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C.

J Clin Oncol. 2016 Nov 14:JCO2015661389. [Epub ahead of print]

PMID: 28068177

 

Identification of Tricyclic Agonists of Sphingosine-1-phosphate Receptor 1 (S1P₁) Employing Ligand-Based Drug Design.

Xiao HY, Watterson SH, Langevine CM, Srivastava AS, Ko SS, Zhang Y, Cherney RJ, Guo WW, Gilmore JL, Sheppeck JE 2nd, Wu DR, Li P, Ramasamy D, Arunachalam P, Mathur A, Taylor TL, Shuster DJ, McIntyre KW, Shen DR, Yarde M, Cvijic ME, Marino AM, Balimane PV, Yang Z, Banas DM, Cornelius G, D'Arienzo CJ, Warrack BM, Lehman-McKeeman L, Salter-Cid LM, Xie J, Barrish JC, Carter PH, Dyckman AJ, Dhar TG.

J Med Chem. 2016 Nov 10;59(21):9837-9854.

PMID: 27726358

 

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.

Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML.

N Engl J Med. 2016 Nov 10;375(19):1856-1867.

PMID: 27718784

 

Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy.

Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A.

N Engl J Med. 2016 Nov 10;375(19):1845-1855.

PMID: 27717298

 

Untargeted screening of unknown xenobiotics and potential toxins in plasma of poisoned patients using high-resolution mass spectrometry: Generation of xenobiotic fingerprint using background subtraction.

Chen C, Wohlfarth A, Xu H, Su D, Wang X, Jiang H, Feng Y, Zhu M.

Anal Chim Acta. 2016 Nov 9;944:37-43. doi: 10.1016/j.aca.2016.09.034.

PMID: 27776637

 

Pd-Catalyzed γ-C(sp₃)-H Arylation of Free Amines Using a Transient Directing Group.

Wu Y, Chen YQ, Liu T, Eastgate MD, Yu JQ.

J Am Chem Soc. 2016 Nov 9;138(44):14554-14557.

PMID: 27786439

 

Development of an HTS-Compatible Assay for Discovery of Melanoma-Related Microphthalmia Transcription Factor Disruptors Using AlphaScreen Technology.

Wang J, Fang P, Chase P, Tshori S, Razin E, Spicer TP, Scampavia L, Hodder P, Guo M.

J Biomol Screen. 2016 Nov 8. pii: 1087057116675274. [Epub ahead of print]

PMID: 27827304

 

Advances in analytical methodologies to guide bioprocess engineering for bio-therapeutics.

Saldova R, Kilcoyne M, Stöckmann H, Millán Martín S, Lewis AM, Tuite CM, Gerlach JQ, Le Berre M, Borys MC, Li ZJ, Abu-Absi NR, Leister K, Joshi L, Rudd PM.

Methods. 2016 Nov 8. pii: S1046-2023(16)30434-0. doi: 10.1016/j.ymeth.2016.11.002. [Epub ahead of print]

PMID: 27832969

 

A Phase I/II Multicenter Study of Single-Agent Foretinib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma.

Yau TC, Lencioni R, Sukeepaisarnjaroen W, Chao Y, Yen CJ, Lausoontornsiri W, Chen PJ, Sanpajit T, Camp A, Cox DS, Gagnon RC, Liu Y, Raffensperger KE, Kulkarni DA, Kallender H, Ottesen LH, Poon RT, Bottaro DP.

Clin Cancer Res. 2016 Nov 7. pii: clincanres.1789.2016. [Epub ahead of print]

PMID: 27821605

 

Understanding the Impact of Chemical Variability and Calibration Algorithms on Prediction of Solid Fraction of Roller Compacted Ribbons Using Near-Infrared (NIR) Spectroscopy.

Talwar S, Nunes C, Stevens T, Nesarikar V, Timmins P, Anderson CA, Drennen JK 3rd.

Appl Spectrosc. 2016 Nov 4. pii: 0003702816671960. [Epub ahead of print]

PMID: 27815436

 

Erratum to: Agonist anti-GITR monoclonal antibody and stereotactic radiation induce immune-mediated survival advantage in murine intracranial glioma.

Patel MA, Kim JE, Theodros D, Tam A, Velarde E, Kochel CM, Francica B, Nirschl TR, Ghasemzadeh A, Mathios D, Harris-Bookman S, Jackson CC, Jackson C, Ye X, Tran PT, Tyler B, Coric V, Selby M, Brem H, Drake CG, Pardoll DM, Lim M.

J Immunother Cancer. 2016 Nov 4;4:74.

PMID: 27822377

 

Reply to Letter to the Editor.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Nov 3. doi: 10.1002/art.39978. [Epub ahead of print] Review. No abstract available.

PMID: 27813366

 

Fulminant Myocarditis with Combination Immune Checkpoint Blockade.

Johnson DB, Balko JM, Compton ML, Chalkias S, Gorham J, Xu Y, Hicks M, Puzanov I, Alexander MR, Bloomer TL, Becker JR, Slosky DA, Phillips EJ, Pilkinton MA, Craig-Owens L, Kola N, Plautz G, Reshef DS, Deutsch JS, Deering RP, Olenchock BA, Lichtman AH, Roden DM, Seidman CE, Koralnik IJ, Seidman JG, Hoffman RD, Taube JM, Diaz LA Jr, Anders RA, Sosman JA, Moslehi JJ.

N Engl J Med. 2016 Nov 3;375(18):1749-1755.

PMID: 27806233

 

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.

Wu B, Chung S, Jiang XR, McNally J, Pedras-Vasconcelos J, Pillutla R, White JT, Xu Y, Gupta S.

AAPS J. 2016 Nov;18(6):1335-1350.

PMID: 27495119

 

Challenges and Opportunities with Non-CYP Enzymes Aldehyde Oxidase, Carboxylesterase, and UDP-Glucuronosyltransferase: Focus on Reaction Phenotyping and Prediction of Human Clearance.

Argikar UA, Potter PM, Hutzler JM, Marathe PH.

AAPS J. 2016 Nov;18(6):1391-1405. Review.

PMID: 27495117

 

Design and Synthesis of Novel Meta-Linked Phenylglycine Macrocyclic FVIIa Inhibitors.

Richter JM, Cheney DL, Bates JA, Wei A, Luettgen JM, Rendina AR, Harper TM, Narayanan R, Wong PC, Seiffert D, Wexler RR, Priestley ES.

ACS Med Chem Lett. 2016 Nov 1;8(1):67-72. doi: 10.1021/acsmedchemlett.6b00375.

PMID: 28105277

 

A Review of Daclatasvir Drug-Drug Interactions.

Garimella T, You X, Wang R, Huang SP, Kandoussi H, Bifano M, Bertz R, Eley T.

Adv Ther. 2016 Nov;33(11):1867-1884. Review.

PMID: 27664109

 

 Long-Term Outcomes in Belatacept- Versus Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT-EXT, a Phase III Randomized Study.

Durrbach A, Pestana JM, Florman S, Del Carmen Rial M, Rostaing L, Kuypers D, Matas A, Wekerle T, Polinsky M, Meier-Kriesche HU, Munier S, Grinyó JM.

Am J Transplant. 2016 Nov;16(11):3192-3201. doi: 10.1111/ajt.13830.

PMID: 27130868

 

Daclatasvir and Peginterferon/Ribavirin for Black/African-American and Latino Patients with HCV infection.

Rodriguez-Torres M, Lawitz E, Yangco B, Jeffers L, Han SH, Thuluvath PJ, Rustgi V, Harrison S, Ghalib R, Vierling JM, Luketic V, Zamor PJ, Ravendhran N, Morgan TR, Pearlman B, O'Brien C, Khallafi H, Pyrsopoulos N, Kong G, McPhee F, Yin PD, Hughes E, Treitel M.

Ann Hepatol. 2016 Nov-Dec 2016;15(6):834-845.

PMID: 27740516

 

Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma.

Mateos MV, Granell M, Oriol A, Martinez-Lopez J, Blade J, Hernandez MT, Martín J, Gironella M, Lynch M, Bleickardt E, Paliwal P, Singhal A, San-Miguel J.

Br J Haematol. 2016 Nov;175(3):448-456. doi: 10.1111/bjh.14263.

PMID: 27434748

 

Agonistic CD40 mAb-Driven IL12 Reverses Resistance to Anti-PD1 in a T-cell-Rich Tumor.

Ngiow SF, Young A, Blake SJ, Hill GR, Yagita H, Teng MW, Korman AJ, Smyth MJ.

Cancer Res. 2016 Nov 1;76(21):6266-6277.

PMID: 27634762

 

Highlights From the American Association of Pharmaceutical Scientists/ International Transporter Consortium Joint Workshop on Drug Transporters in Absorption, Distribution, Metabolism, and Excretion: From the Bench to the Bedside - Clinical Pharmacology Considerations.

Ronaldson PT, Bauer B, El-Kattan AF, Shen H, Salphati L, Louie SW.

Clin Pharmacol Ther. 2016 Nov;100(5):419-422. doi: 10.1002/cpt.439.

PMID: 27500791

 

Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects.

Theunissen PT, Beken S, Beyer BK, Breslin WJ, Cappon GD, Chen CL, Chmielewski G, De Schaepdrijver L, Enright B, Foreman JE, Harrouk W, Hew KW, Hoberman AM, Hui JY, Knudsen TB, Laffan SB, Makris SL, Martin M, McNerney ME, Siezen CL, Stanislaus DJ, Stewart J, Thompson KE, Tornesi B, Van der Laan JW, Weinbauer GF, Wood S, Piersma AH.

Crit Rev Toxicol. 2016 Nov;46(10):900-910.

PMID: 27848393

 

One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.

Matthaei S, Aggarwal N, Garcia-Hernandez P, Iqbal N, Chen H, Johnsson E, Chin A, Hansen L.

Diabetes Obes Metab. 2016 Nov;18(11):1128-1133. doi: 10.1111/dom.12741.

PMID: 27403645

 

Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes.

Mathieu C, Herrera Marmolejo M, González González JG, Hansen L, Chen H, Johnsson E, Garcia-Sanchez R, Iqbal N.

Diabetes Obes Metab. 2016 Nov;18(11):1134-1137. doi: 10.1111/dom.12737.

PMID: 27385192

 

Transporter Expression in Liver Tissue from Subjects with Alcoholic or Hepatitis C Cirrhosis Quantified by Targeted Quantitative Proteomics.

Wang L, Collins C, Kelly EJ, Chu X, Ray AS, Salphati L, Xiao G, Lee C, Lai Y, Liao M, Mathias A, Evers R, Humphreys W, Hop CE, Kumer SC, Unadkat JD.

Drug Metab Dispos. 2016 Nov;44(11):1752-1758.

PMID: 27543206

 

Non-cytochrome P450-mediated bioactivation and its toxicological relevance.

Gan J, Ma S, Zhang D.

Drug Metab Rev. 2016 Nov;48(4):473-501.

PMID: 27533622

 

Hepatitis C disease transmission and treatment uptake: impact on the cost-effectiveness of new direct-acting antiviral therapies.

Bennett H, Gordon J, Jones B, Ward T, Webster S, Kalsekar A, Yuan Y, Brenner M, McEwan P.

Eur J Health Econ. 2016 Nov 1. [Epub ahead of print]

PMID: 27803989

 

Systematic review of renal and bone safety of the antiretroviral regimen efavirenz, emtricitabine, and tenofovir disoproxil fumarate in patients with HIV infection.

Bedimo R, Rosenblatt L, Myers J.

HIV Clin Trials. 2016 Nov;17(6):246-266.

PMID: 27809711

 

Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial.

Yang W, Han P, Min KW, Wang B, Mansfield T, T'Joen C, Iqbal N, Johnsson E, Ptaszynska A.

J Diabetes. 2016 Nov;8(6):796-808. doi: 10.1111/1753-0407.12357.

PMID: 26589253

 

A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin.

Wei L, Zhang M, Xu M, Chuang WL, Lu W, Xie W, Jia Z, Gong G, Li Y, Bae SH, Yang YF, Xie Q, Lin S, Chen X, Niu J, Jia J, Garimella T, Torbeyns A, McPhee F, Treitel M, Yin PD, Mo L.

J Gastroenterol Hepatol. 2016 Nov;31(11):1860-1867. doi: 10.1111/jgh.13379.

PMID: 27003037

 

Mechanisms of Hyperbilirubinemia During Peginterferon Lambda-1a Therapy for Chronic Hepatitis C Infection: A Retrospective Investigation.

Zwirtes R, Narasimhan P, Wind-Rotolo MM, Xu D, Hruska MW, Kishnani N, Colston EM, Srinivasan S.

J Interferon Cytokine Res. 2016 Nov;36(11):644-651.

PMID: 27710263

 

Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b.

Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S.

J Interferon Cytokine Res. 2016 Nov;36(11):635-643.

PMID: 27327078

 

Cardiovascular Outcomes Associated with Lowering Low-density Lipoprotein Cholesterol in Rheumatoid Arthritis and Matched Nonrheumatoid Arthritis.

An J, Alemao E, Reynolds K, Kawabata H, Solomon DH, Liao KP, Niu F, Cheetham TC.

J Rheumatol. 2016 Nov;43(11):1989-1996.

PMID: 27585690

  

PS01.74: Systemic Treatment Sequencing in US Medicare Patients with Extensive Disease (ED)-Small Cell Lung Cancer (SCLC): Topic: Medical Oncology.

Danese M, Gleeson M, Lubeck D, Korytowsky B, Bobiak S.

J Thorac Oncol. 2016 Nov;11(11S):S317-S318. doi: 10.1016/j.jtho.2016.09.109. No abstract available.

PMID: 27969541

 

PS01.73: Have We Shifted the Therapeutic Innovation Frontier? A US Assessment of Advanced Non-Small Cell Lung Cancer (advNSCLC): Topic: Medical Oncology.

Korytowsky B, Justo N, Nilsson J, Madison T, Dalen J, McGuire A.

J Thorac Oncol. 2016 Nov;11(11S):S316-S317. doi: 10.1016/j.jtho.2016.09.108. No abstract available.

PMID: 27969540

 

PS01.59: CheckMate 370: A Master Protocol of Phase 1/2 Studies of Nivolumab as Maintenance or First-Line ± Standard-of-Care Therapies in Advanced NSCLC: Topic: Medical Oncology.

Blumenschein G Jr, Chandler J, Garon EB, Waterhouse D, Goldman JW, Gunuganti VK, Boccia R, Spigel D, Glaspy J, Berry DA, Korytowsky B, Zhu J, Lin WH, Bennett K, Reynolds C.

J Thorac Oncol. 2016 Nov;11(11S):S307. doi: 10.1016/j.jtho.2016.09.094. No abstract available.

PMID: 27969526

 

PS01.58: A Phase 3 Trial of Nivolumab, Nivolumab Plus Ipilimumab, or Placebo Maintenance for Extensive-Stage SCLC After First-Line Chemotherapy: Topic: Medical Oncology.

Owonikoko T, Ready N, Postmus P, Reck M, Peters S, Pieters A, Selvaggi G, Fairchild J, Govindan R.

J Thorac Oncol. 2016 Nov;11(11S):S306-S307. doi: 10.1016/j.jtho.2016.09.093. No abstract available.

PMID: 27969525

 

ORAL01.03: CheckMate 012: Safety and Efficacy of First-Line Nivolumab and Ipilimumab in Advanced NSCLC: Topic: Medical Oncology.

Antonia SJ, Gettinger SN, Goldman J, Brahmer J, Borghaei H, Chow LQ, Ready NE, Gerber DE, Juergens R, Shepherd F, Laurie SA, Young T, Geese WJ, Agrawal S, Li X, Hellmann MD.

J Thorac Oncol. 2016 Nov;11(11S):S250-S251. doi: 10.1016/j.jtho.2016.09.008. No abstract available.

PMID: 27969442

 

ORAL01.02: Biopsies in Initial Diagnosis of Non-Small Cell Lung Cancer in US Community Oncology Practices: Implications for First-Line Immunotherapy: Topic: Medical Oncology.

Hussein M, Richards DA, Ulrich B, Korytowsky B, Pandya D, Cogswell J, Batenchuk C, Burns V.

J Thorac Oncol. 2016 Nov;11(11S):S249-S250. doi: 10.1016/j.jtho.2016.09.007. No abstract available.

PMID: 27969441

 

Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial.

Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE.

Lancet Oncol. 2016 Nov;17(11):1590-1598. doi: 10.1016/S1470-2045(16)30496-X.

PMID: 27733243

 

Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.

Hodi FS, Chesney J, Pavlick AC, Robert C, Grossmann KF, McDermott DF, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor DR, Salama AK, Taylor MH, Ott PA, Horak C, Gagnier P, Jiang J, Wolchok JD, Postow MA.

Lancet Oncol. 2016 Nov;17(11):1558-1568. doi: 10.1016/S1470-2045(16)30366-7.

PMID: 27622997

 

On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir.

Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K.

Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165.

PMID: 27188960

 

Some practical considerations in three-arm non-inferiority trial design.

Zhou M, Kundu S.

Pharm Stat. 2016 Nov;15(6):550-559. doi: 10.1002/pst.1779.

PMID: 27681603

 

Autoxidation Products of Betulonaldehyde.

Ayers S, Benkovics T, Marshall J, Tan Y, Strotman NA, Kiau S.

J Nat Prod. 2016 Oct 28;79(10):2758-2761.

PMID: 27684353

 

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non-Small-Cell Lung Cancer (RTOG 3505).

Gerber DE, Urbanic JJ, Langer C, Hu C, Chang IF, Lu B, Movsas B, Jeraj R, Curran WJ, Bradley JD.

Clin Lung Cancer. 2016 Oct 26. pii: S1525-7304(16)30352-7. doi: 10.1016/j.cllc.2016.10.009. [Epub ahead of print]

PMID: 27923550

 

Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation.

Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB.

Heart. 2016 Oct 24. pii: heartjnl-2016-309901. doi: 10.1136/heartjnl-2016-309901. [Epub ahead of print]

PMID: 27798052

 

Discovery of Highly Potent Liver X Receptor β Agonists.

Kick EK, Busch BB, Martin R, Stevens WC, Bollu V, Xie Y, Boren BC, Nyman MC, Nanao MH, Nguyen L, Plonowski A, Schulman IG, Yan G, Zhang H, Hou X, Valente MN, Narayanan R, Behnia K, Rodrigues AD, Brock B, Smalley J, Cantor GH, Lupisella J, Sleph P, Grimm D, Ostrowski J, Wexler RR, Kirchgessner T, Mohan R.

ACS Med Chem Lett. 2016 Oct 23;7(12):1207-1212.

PMID: 27994765

 

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects.

Theunissen PT, Beken S, Beyer B, Breslin WJ, Cappon GD, Chen CL, Chmielewski G, de Schaepdrijver L, Enright B, Foreman JE, Harrouk W, Hew KW, Hoberman AM, Y Hui J, Knudsen TB, Laffan SB, Makris SL, Martin M, McNerney ME, Siezen CL, Stanislaus DJ, Stewart J, Thompson KE, Tornesi B, Van der Laan JW, Weinbauer GF, Wood S, Piersma AH.

Crit Rev Toxicol. 2016 Oct 21:1-13. [Epub ahead of print]

PMID: 27766926

 

Dual roles for regulatory T cell depletion and co-stimulatory signaling in agonistic GITR targeting for tumor immunotherapy.

Mahne A, Mauze S, Joyce-Shaikh B, Xia J, Bowman E, Beebe A, Cua D, Jain R.

Cancer Res. 2016 Oct 20. pii: canres.0797.2016. doi: 10.1158/0008-5472.CAN-16-0797. [Epub ahead of print]

PMID: 28122327

 

Results From an Integrated Safety Analysis of Urelumab, an Agonist Anti-CD137 Monoclonal Antibody.

Segal NH, Logan TF, Hodi FS, McDermott DF, Melero I, Hamid O, Schmidt H, Robert C, Chiarion-Sileni V, Ascierto PA, Maio M, Urba WJ, Gangadhar TC, Suryawanshi S, Neely J, Jure-Kunkel M, Krishnan S, Kohrt HE, Sznol M, Levy R.

Clin Cancer Res. 2016 Oct 18. pii: clincanres.1272.2016. [Epub ahead of print]

PMID: 27756788

 

A Randomized Study of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a in Combination with Ribavirin and Telaprevir in Patients with Genotype-1 Chronic Hepatitis C.

Flisiak R, Shiffman M, Arenas J, Cheinquer H, Nikitin I, Dong Y, Rana K, Srinivasan S.

PLoS One. 2016 Oct 17;11(10):e0164563. doi: 10.1371/journal.pone.0164563.

PMID: 27749900

 

Regulatory Forum*: Progress toward ICH S1 Revision.

Peden WM.

Toxicol Pathol. 2016 Oct 17. pii: 0192623316673201. [Epub ahead of print]

PMID: 27753636

 

Synthesis and P1' SAR exploration of potent macrocyclic tissue factor-factor VIIa inhibitors.

Ladziata VU, Glunz PW, Zou Y, Zhang X, Jiang W, Jacutin-Porte S, Cheney DL, Wei A, Luettgen JM, Harper TM, Wong PC, Seiffert D, Wexler RR, Priestley ES.

Bioorg Med Chem Lett. 2016 Oct 15;26(20):5051-5057. doi: 10.1016/j.bmcl.2016.08.088.

PMID: 27612545

 

Abscopal Effects of Radiotherapy Are Enhanced by Combined Immunostimulatory mAbs and Are Dependent on CD8 T Cells and Crosspriming.

Rodriguez-Ruiz ME, Rodriguez I, Garasa S, Barbes B, Solorzano JL, Perez-Gracia JL, Labiano S, Sanmamed MF, Azpilikueta A, Bolaños E, Sanchez-Paulete AR, Aznar MA, Rouzaut A, Schalper KA, Jure-Kunkel M, Melero I.

Cancer Res. 2016 Oct 15;76(20):5994-6005.

PMID: 27550452

 

Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BTK) Conformationally Constrained by Two Locked Atropisomers.

Watterson SH, De Lucca GV, Shi Q, Langevine CM, Liu Q, Batt DG, Beaudoin Bertrand M, Gong H, Dai J, Yip S, Li P, Sun D, Wu DR, Wang C, Zhang Y, Traeger SC, Pattoli MA, Skala S, Cheng L, Obermeier MT, Vickery R, Discenza LN, D'Arienzo CJ, Zhang Y, Heimrich E, Gillooly KM, Taylor TL, Pulicicchio C, McIntyre KW, Galella MA, Tebben AJ, Muckelbauer JK, Chang C, Rampulla R, Mathur A, Salter-Cid L, Barrish JC, Carter PH, Fura A, Burke JR, Tino JA.

J Med Chem. 2016 Oct 13;59(19):9173-9200.

PMID: 27583770

 

Synthesis and Antiobesity Properties of 6-(4-Chlorophenyl)-3-(4-((3,3-difluoro-1-hydroxycyclobutyl)methoxy)-3-methoxyphenyl)thieno[3,2-d]pyrimidin-4(3H)-one (BMS-814580): A Highly Efficacious Melanin Concentrating Hormone Receptor 1 (MCHR1) Inhibitor.

Ahmad S, Washburn WN, Hernandez AS, Bisaha S, Ngu K, Wang W, Pelleymounter MA, Longhi D, Flynn N, Azzara AV, Rohrbach K, Devenny J, Rooney S, Thomas M, Glick S, Godonis H, Harvey S, Zhang H, Gemzik B, Janovitz EB, Huang C, Zhang L, Robl JA, Murphy BJ.

J Med Chem. 2016 Oct 13;59(19):8848-8858.

PMID: 27564419

 

Evaluation and selection of a non-PCR based technology for improved gene expression profiling from clinical formalin-fixed, paraffin-embedded samples.

Qi Z, Wang L, He A, Ma-Edmonds M, Cogswell J.

Bioanalysis. 2016 Oct 7. [Epub ahead of print]

PMID: 27712086

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

Yang E, Welink J, Cape S, Woolf E, Sydor J, James C, Goykhman D, Arnold M, Addock N, Bauer R, Buonarati M, Ciccimaro E, Dodda R, Evans C, Garofolo F, Hughes N, Islam R, Nehls C, Wilson A, Briscoe C, Bustard M, Coppola L, Croft S, Drexler D, Ferrari L, Fraier D, Jenkins R, Kadavil J, King L, Li W, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Sun R, Tampal N, Vinter S, Wakelin-Smith J, Yue Q.

Bioanalysis. 2016 Oct 7. [Epub ahead of print]

PMID: 27712081

 

Erratum to: Risk of cardiovascular events among patients with HIV treated with atazanavircontaining regimens: a retrospective cohort study.

Rosenblatt L, Farr AM, Nkhoma ET, Nelson JK, Ritchings C, Johnston SS.

BMC Infect Dis. 2016 Oct 7;16(1):547. No abstract available.

PMID: 27717332

 

The 'obesity paradox' in atrial fibrillation: observations from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial.

Sandhu RK, Ezekowitz J, Andersson U, Alexander JH, Granger CB, Halvorsen S, Hanna M, Hijazi Z, Jansky P, Lopes RD, Wallentin L.

Eur Heart J. 2016 Oct 7;37(38):2869-2878.

PMID: 27071819

 

Synthesis of Fmoc-Protected Arylphenylalanines (Bip Derivatives) via Nonaqueous Suzuki-Miyaura Cross-Coupling Reactions.

Qiao JX, Fraunhoffer KJ, Hsiao Y, Li YX, Wang C, Wang TC, Poss MA.

J Org Chem. 2016 Oct 7;81(19):9499-9506.

PMID: 27615449

 

Novel platens to measure the hardness of a pentagonal shaped tablet.

Malladi J, Sidik K, Wu S, McCann R, Dougherty J, Parab P, Carragher T.

Pharm Dev Technol. 2016 Oct 4:1-10. [Epub ahead of print]

PMID: 27607150

 

Development of 1H-Pyrazolo[3,4-b]pyridines as Metabotropic Glutamate Receptor 5 Positive Allosteric Modulators.

Hill MD, Fang H, Brown JM, Molski T, Easton A, Han X, Miller R, Hill-Drzewi M, Gallagher L, Matchett M, Gulianello M, Balakrishnan A, Bertekap RL, Santone KS, Whiterock VJ, Zhuo X, Bronson JJ, Macor JE, Degnan AP.

ACS Med Chem Lett. 2016 Oct 3;7(12):1082-1086.

PMID: 27994742

 

Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective.

Lineberry N, Berlin JA, Mansi B, Glasser S, Berkwits M, Klem C, Bhattacharya A, Citrome L, Enck R, Fletcher J, Haller D, Chen TT, Laine C.

BMJ. 2016 Oct 3;355:i5078. doi: 10.1136/bmj.i5078. No abstract available.

PMID: 27697753

 

In-line ATR-UV and Raman Spectroscopy for Monitoring API Dissolution Process During Liquid-Filled Soft-Gelatin Capsule Manufacturing.

Wan B, Zordan CA, Lu X, McGeorge G.

AAPS PharmSciTech. 2016 Oct;17(5):1173-81. doi: 10.1208/s12249-015-0456-0.

PMID: 26604007

 

Establishing a complementary diagnostic for anti-PD-1 immune checkpoint inhibitor therapy.

Novotny JF Jr, Cogswell J, Inzunza H, Harbison C, Horak C, Averbuch S.

Ann Oncol. 2016 Oct;27(10):1966-9. doi: 10.1093/annonc/mdw288. No abstract available.

PMID: 27502705

 

Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase III CheckMate 066 study.

Long GV, Atkinson V, Ascierto PA, Robert C, Hassel JC, Rutkowski P, Savage KJ, Taylor F, Coon C, Gilloteau I, Dastani HB, Waxman IM, Abernethy AP.

Ann Oncol. 2016 Oct;27(10):1940-6. doi: 10.1093/annonc/mdw265.

PMID: 27405322

 

Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study.

D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force..

Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709.

PMID: 26590174

 

A validated LC-MS/MS method for the quantitative measurement of creatinine as an endogenous biomarker in human plasma.

Zhao Y, Liu G, Angeles A, Christopher LJ, Wang Z, Arnold ME, Shen JX.

Bioanalysis. 2016 Oct;8(19):1997-2005. doi: 10.4155/bio-2016-0086.

PMID: 27611058

 

HCV NS5A replication complex inhibitors.

Gao M, O'Boyle DR 2nd, Roberts S.

Curr Opin Pharmacol. 2016 Oct;30:151-157. doi: 10.1016/j.coph.2016.07.014. Review.

PMID: 27643675

 

Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial.

Wysham CH, MacConell L, Hardy E.

Diabetes Care. 2016 Oct;39(10):1768-76. doi: 10.2337/dc16-0238.

PMID: 27436275

 

Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective.

Fahmi OA, Shebley M, Palamanda J, Sinz MW, Ramsden D, Einolf HJ, Chen L, Wang H.

Drug Metab Dispos. 2016 Oct;44(10):1720-30. doi: 10.1124/dmd.116.071076.

PMID: 27422672

 

Oxygen-dependent regulation of c-di-GMP synthesis by SadC controls alginate production in Pseudomonas aeruginosa.

Schmidt A, Hammerbacher AS, Bastian M, Nieken KJ, Klockgether J, Merighi M, Lapouge K, Poschgan C, Kölle J, Acharya KR, Ulrich M, Tümmler B, Unden G, Kaever V, Lory S, Haas D, Schwarz S, Döring G.

Environ Microbiol. 2016 Oct;18(10):3390-3402. doi: 10.1111/1462-2920.13208.

PMID: 26743546

 

Novel statistical approach for evaluating flow cytometric in vitro micronucleus data.

Wojciechowski JP, Gleason CR, Roberts DJ, Custer LL.

Environ Mol Mutagen. 2016 Oct;57(8):623-629. doi: 10.1002/em.22038.

PMID: 27545269

 

P2.46 (also presented as PD1.01): LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057: Track: Immunotherapy.

Gralla RJ, Spigel D, Bennett B, Taylor F, Penrod JR, Derosa M, Dastani H, Orsini L, Mathias C, Reck M.

J Thorac Oncol. 2016 Oct;11(10S):S247. doi: 10.1016/j.jtho.2016.08.117. No abstract available.

PMID: 27676580

 

P2.36: Nivolumab (nivo) in Patients (pts) With Advanced (adv) NSCLC and Central Nervous System (CNS) Metastases (mets): Track: Immunotherapy.

Goldman JW, Crino L, Vokes EE, Holgado E, Reckamp K, Pluzanski A, Spigel D, Kohlhaeufl M, Garassino M, Chow LQ, Gettinger S, Gerber DE, Havel L, Ramalingam SS, Dy GK, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Lopes G.

J Thorac Oncol. 2016 Oct;11(10S):S238-S239. doi: 10.1016/j.jtho.2016.08.107. No abstract available.

PMID: 27676570

 

P2.35: Nivolumab vs Docetaxel in Advanced NSCLC: CheckMate 017/057 2-Y Update and Exploratory Cytokine Profile Analysis: Track: Immunotherapy.

Borghaei H, Brahmer J, Horn L, Ready N, Steins M, Felip E, Paz-Ares L, Xx X, Barlesi F, Antonia S, Fayette J, Rizvi N, Crino L, Reck M, Erich Eberhardt WE, Hellmann M, Desai K, Li A, Healey D, Spigel D, Mathias C.

J Thorac Oncol. 2016 Oct;11(10S):S237-S238. doi: 10.1016/j.jtho.2016.08.106. No abstract available.

PMID: 27676569

 

P2.33: Safety Profile of Nivolumab Administered as 30-Minute (MIN) Infusion: Analysis of Data From Checkmate 153: Track: Immunotherapy.

Waterhouse D, Horn L, Reynolds C, Spigel D, Chandler J, Mekhail T, Mohamed M, Creelan B, Blankstein KB, Nikolinakos P, Mccleod MJ, Li A, Waxman IM, Aanur N, Agrawal S, Richardet E.

J Thorac Oncol. 2016 Oct;11(10S):S236. doi: 10.1016/j.jtho.2016.08.104. No abstract available.

PMID: 27676567

 

PD1.01 (also presented as P2.46): LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057.

Gralla RJ, Spigel D, Bennett B, Taylor F, Penrod JR, Derosa M, Dastani H, Orsini L, Mathias C, Reck M.

J Thorac Oncol. 2016 Oct;11(10S):S171. doi: 10.1016/j.jtho.2016.08.009. No abstract available.

PMID: 27676476

  

All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study.

Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S.

Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128.

PMID: 27009831

 

Investigating investment in biopharmaceutical R&D.

Carter PH, Berndt ER, DiMasi JA, Trusheim M.

Nat Rev Drug Discov. 2016 Oct;15(10):673-4. doi: 10.1038/nrd.2016.104. No abstract available.

PMID: 27616295

 

Initial Drug Dissolution from Amorphous Solid Dispersions Controlled by Polymer Dissolution and Drug-Polymer Interaction.

Chen Y, Wang S, Wang S, Liu C, Su C, Hageman M, Hussain M, Haskell R, Stefanski K, Qian F.

Pharm Res. 2016 Oct;33(10):2445-58. doi: 10.1007/s11095-016-1969-2.

PMID: 27283830

 

Effects of BMS-986094, a Guanosine Nucleotide Analogue, on Mitochondrial DNA Synthesis and Function.

Baumgart BR, Wang F, Kwagh J, Storck C, Euler C, Fuller M, Simic D, Sharma S, Arnold JJ, Cameron CE, Van Vleet TR, Flint O, Bunch RT, Davies MH, Graziano MJ, Sanderson TP.

Toxicol Sci. 2016 Oct;153(2):396-408. doi: 10.1093/toxsci/kfw135.

PMID: 27466212

 

Mixtures, Metabolites, and Mechanisms: Understanding Toxicology Using Zebrafish.

Gamse JT, Gorelick DA.

Zebrafish. 2016 Oct;13(5):377-8. doi: 10.1089/zeb.2016.1370.

PMID: 27618129

 

Early real-world evidence of persistence on oral anticoagulants for stroke prevention in non-valvular atrial fibrillation: a cohort study in UK primary care.

Johnson ME, Lefèvre C, Collings SL, Evans D, Kloss S, Ridha E, Maguire A.

BMJ Open. 2016 Sep 26;6(9):e011471. doi: 10.1136/bmjopen-2016-011471.

PMID: 27678530

 

 Discovery of S3-Truncated, C-6 Heteroaryl Substituted Aminothiazine β-Site APP Cleaving Enzyme-1 (BACE1) Inhibitors.

Wu YJ, Guernon J, Shi J, Marcin L, Higgins M, Rajamani R, Muckelbauer J, Lewis H, Chang C, Camac D, Toyn JH, Ahlijanian MK, Albright CF, Macor JE, Thompson LA.

J Med Chem. 2016 Sep 22;59(18):8593-600. doi: 10.1021/acs.jmedchem.6b01012.

PMID: 27559936

 

Discovery, Synthesis, and Preclinical Characterization of N-(3-Chloro-4-fluorophenyl)-1H-pyrazolo[4,3-b]pyridin-3-amine (VU0418506), a Novel Positive Allosteric Modulator of the Metabotropic Glutamate Receptor 4 (mGlu4).

Engers DW, Blobaum AL, Gogliotti RD, Cheung YY, Salovich JM, Garcia-Barrantes PM, Daniels JS, Morrison R, Jones CK, Soars MG, Zhuo X, Hurley J, Macor JE, Bronson JJ, Conn PJ, Lindsley CW, Niswender CM, Hopkins CR.

ACS Chem Neurosci. 2016 Sep 21;7(9):1192-200. doi: 10.1021/acschemneuro.6b00035.

PMID: 27075300

 

Population pharmacokinetics of exenatide.

Cirincione B, Mager DE.

Br J Clin Pharmacol. 2016 Sep 21. doi: 10.1111/bcp.13135. [Epub ahead of print]

PMID: 27650681

 

Risk of cardiovascular events among patients with HIV treated with atazanavir-containing regimens: a retrospective cohort study.

Rosenblatt L, Farr AM, Nkhoma ET, Nelson JK, Ritchings C, Johnston SS.

BMC Infect Dis. 2016 Sep 19;16:492. doi: 10.1186/s12879-016-1827-1. Erratum in: BMC Infect Dis. 2016 Oct 7;16(1):547.

PMID: 27643691

 

 Discovery of Phenylglycine Lactams as Potent Neutral Factor VIIa Inhibitors.

Wurtz NR, Parkhurst BL, Jiang W, DeLucca I, Zhang X, Ladziata V, Cheney DL, Bozarth JR, Rendina AR, Wei A, Luettgen JM, Wu Y, Wong PC, Seiffert DA, Wexler RR, Priestley ES.

ACS Med Chem Lett. 2016 Sep 17;7(12):1077-1081.

PMID: 27994741

 

Overview of Critical Parameters for the Design and Execution of a High-Throughput Screen for Allosteric Ligands.

Alt A.

Curr Protoc Pharmacol. 2016 Sep 16;74:9.20.1-9.20.23. doi: 10.1002/cpph.12.

PMID: 27636112

 

Bioequivalence and food effect of heat-stressed and non-heat-stressed dapagliflozin 2.5- and 10-mg tablets.

LaCreta F, Griffen SC, Liu X, Smith C, Hines C, Volk K, Tejwani R, Boulton DW.

Int J Pharm. 2016 Sep 10;511(1):288-95. doi: 10.1016/j.ijpharm.2016.07.017.

PMID: 27418571

 

An integrated approach for profiling oxidative metabolites and glutathione adducts using liquid chromatography coupled with ultraviolet detection and triple quadrupole-linear ion trap mass spectrometry.

Chen G, Cheng Z, Zhang K, Jiang H, Zhu M.

J Pharm Biomed Anal. 2016 Sep 10;129:482-91. doi: 10.1016/j.jpba.2016.07.048.

PMID: 27497649

 

Definitive Upfront Stereotactic Ablative Radiotherapy Combined with Image-Guided, Intensity Modulated Radiotherapy (IG-IMRT) or IG-IMRT Alone for Locally Advanced Non-Small Cell Lung Cancer.

Chi A, Wen S, Monga M, Almubarak M, He X, Rojanasakul Y, Tse W, Remick SC.

PLoS One. 2016 Sep 9;11(9):e0162453. doi: 10.1371/journal.pone.0162453.

PMID: 27611833

 

Preclinical Development of Ipilimumab and Nivolumab Combination Immunotherapy: Mouse Tumor Models, In Vitro Functional Studies, and Cynomolgus Macaque Toxicology.

Selby MJ, Engelhardt JJ, Johnston RJ, Lu LS, Han M, Thudium K, Yao D, Quigley M, Valle J, Wang C, Chen B, Cardarelli PM, Blanset D, Korman AJ.

PLoS One. 2016 Sep 9;11(9):e0161779. doi: 10.1371/journal.pone.0161779. Erratum in: PLoS One. 2016 Nov 18;11(11):e0167251.

PMID: 27610613

 

Discovery of a Potent Acyclic, Tripeptidic, Acyl Sulfonamide Inhibitor of Hepatitis C Virus NS3 Protease as a Back-up to Asunaprevir with the Potential for Once-Daily Dosing.

Sun LQ, Mull E, Zheng B, D'Andrea S, Zhao Q, Wang AX, Sin N, Venables BL, Sit SY, Chen Y, Chen J, Cocuzza A, Bilder DM, Mathur A, Rampulla R, Chen BC, Palani T, Ganesan S, Arunachalam PN, Falk P, Levine S, Chen C, Friborg J, Yu F, Hernandez D, Sheaffer AK, Knipe JO, Han YH, Schartman R, Donoso M, Mosure K, Sinz MW, Zvyaga T, Rajamani R, Kish K, Tredup J, Klei HE, Gao Q, Ng A, Mueller L, Grasela DM, Adams S, Loy J, Levesque PC, Sun H, Shi H, Sun L, Warner W, Li D, Zhu J, Wang YK, Fang H, Cockett MI, Meanwell NA, McPhee F, Scola PM.

J Med Chem. 2016 Sep 8;59(17):8042-60. doi: 10.1021/acs.jmedchem.6b00821.

PMID: 27564532

 

Small Molecule Reversible Inhibitors of Bruton's Tyrosine Kinase (BTK): Structure-Activity Relationships Leading to the Identification of 7-(2-Hydroxypropan-2-yl)-4-[2-methyl-3-(4-oxo-3,4-dihydroquinazolin-3-yl)phenyl]-9H-carbazole-1-carboxamide (BMS-935177).

De Lucca GV, Shi Q, Liu Q, Batt DG, Beaudoin Bertrand M, Rampulla R, Mathur A, Discenza L, D'Arienzo C, Dai J, Obermeier M, Vickery R, Zhang Y, Yang Z, Marathe P, Tebben AJ, Muckelbauer JK, Chang CJ, Zhang H, Gillooly K, Taylor T, Pattoli MA, Skala S, Kukral DW, McIntyre KW, Salter-Cid L, Fura A, Burke JR, Barrish JC, Carter PH, Tino JA.

J Med Chem. 2016 Sep 8;59(17):7915-35. doi: 10.1021/acs.jmedchem.6b00722.

PMID: 27531604

 

Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort.

Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S.

Gut. 2016 Sep 7. pii: gutjnl-2016-312444. doi: 10.1136/gutjnl-2016-312444. [Epub ahead of print] Erratum in: Gut. 2016 Dec;65(12 ):2060.

PMID: 27605539

 

Redox-Active Esters in Fe-Catalyzed C-C Coupling.

Toriyama F, Cornella J, Wimmer L, Chen TG, Dixon DD, Creech G, Baran PS.

J Am Chem Soc. 2016 Sep 7;138(35):11132-5. doi: 10.1021/jacs.6b07172.

PMID: 27548696

 

Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods.

Esterman AL, Katiyar A, Krishnamurthy G.

J Pharm Biomed Anal. 2016 Sep 5;128:447-54. doi: 10.1016/j.jpba.2016.06.006.

PMID: 27344634

 

Characterization of human metabolism and disposition of levo-tetrahydropalmatine: Qualitative and quantitative determination of oxidative and conjugated metabolites.

Xiao W, Shen G, Zhuang X, Ran X, Zhu M, Li H.

J Pharm Biomed Anal. 2016 Sep 5;128:371-81. doi: 10.1016/j.jpba.2016.06.015.

PMID: 27343900

 

Recommendations on the Development of a Bioanalytical Assay for 4β-Hydroxycholesterol, an Emerging Endogenous Biomarker of CYP3A Activity.

Aubry AF, Dean B, Diczfalusy U, Goodenough A, Iffland A, McLeod J, Weng N, Yang Z.

AAPS J. 2016 Sep;18(5):1056-66. doi: 10.1208/s12248-016-9949-3. Review.

PMID: 27350147

 

Preclinical to Clinical Translation of Antibody-Drug Conjugates Using PK/PD Modeling: a Retrospective Analysis of Inotuzumab Ozogamicin.

Betts AM, Haddish-Berhane N, Tolsma J, Jasper P, King LE, Sun Y, Chakrapani S, Shor B, Boni J, Johnson TR.

AAPS J. 2016 Sep;18(5):1101-16. doi: 10.1208/s12248-016-9929-7.

PMID: 27198897

 

Tissue distribution and tumor uptake of folate receptor-targeted epothilone folate conjugate, BMS-753493, in CD2F1 mice after systemic administration.

Shen H, Wang L, Chen W, Menard K, Hong Y, Tian Y, Bonacorsi SJ, Humphreys WG, Lee FY, Gan J.

Acta Pharm Sin B. 2016 Sep;6(5):460-467.

PMID: 27709015

 

Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial.

Ezekowitz MD, Pollack CV, Sanders P, Halperin JL, Spahr J, Cater N, Petkun W, Breazna A, Kirchhof P, Oldgren J.

Am Heart J. 2016 Sep;179:59-68. doi: 10.1016/j.ahj.2016.06.008.

PMID: 27595680

 

Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034.

Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G.

Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423.

PMID: 27192969

 

Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Sep;68(9):2083-9. doi: 10.1002/art.39714.

PMID: 27111089

 

The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis.

Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S.

Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700.

PMID: 27059799

 

A simple, effective approach for rapid development of high-throughput and reliable LC-MS/MS bioanalytical assays.

Yuan L, Aubry AF, Ji QC.

Bioanalysis. 2016 Sep;8(17):1809-22. doi: 10.4155/bio-2016-0100.

PMID: 27491843

 

Oxazolidinone-based allosteric modulators of mGluR5: Defining molecular switches to create a pharmacological tool box.

Huang H, Degnan AP, Balakrishnan A, Easton A, Gulianello M, Huang Y, Matchett M, Mattson G, Miller R, Santone KS, Senapati A, Shields EE, Sivarao DV, Snyder LB, Westphal R, Whiterock VJ, Yang F, Bronson JJ, Macor JE.

Bioorg Med Chem Lett. 2016 Sep 1;26(17):4165-9. doi: 10.1016/j.bmcl.2016.07.065.

PMID: 27496211

 

Discovery and SAR of pyrrolo[2,1-f][1,2,4]triazin-4-amines as potent and selective PI3Kδ inhibitors.

Bhide RS, Neels J, Qin LY, Ruan Z, Stachura S, Weigelt C, Sack JS, Stefanski K, Gu X, Xie JH, Goldstine CB, Skala S, Pedicord DL, Ruepp S, Dhar TG, Carter PH, Salter-Cid LM, Poss MA, Davies P.

Bioorg Med Chem Lett. 2016 Sep 1;26(17):4256-60. doi: 10.1016/j.bmcl.2016.07.047.

PMID: 27476421

 

CHO cells knocked out for TSC2 display an improved productivity of antibodies under fed batch conditions.

McVey D, Aronov M, Rizzi G, Cowan A, Scott C, Megill J, Russell R, Tirosh B.

Biotechnol Bioeng. 2016 Sep;113(9):1942-52. doi: 10.1002/bit.25951.

PMID: 26888596

 

Combined metabolomics and proteomics reveals hypoxia as a cause of lower productivity on scale-up to a 5000-liter CHO bioprocess.

Gao Y, Ray S, Dai S, Ivanov AR, Abu-Absi NR, Lewis AM, Huang Z, Xing Z, Borys MC, Li ZJ, Karger BL.

Biotechnol J. 2016 Sep;11(9):1190-200. doi: 10.1002/biot.201600030.

PMID: 27213298

 

Large Cell Neuroendocrine Carcinoma of the Lung: Clinico-Pathologic Features, Treatment, and Outcomes.

Naidoo J, Santos-Zabala ML, Iyriboz T, Woo KM, Sima CS, Fiore JJ, Kris MG, Riely GJ, Lito P, Iqbal A, Veach S, Smith-Marrone S, Sarkaria IS, Krug LM, Rudin CM, Travis WD, Rekhtman N, Pietanza MC.

Clin Lung Cancer. 2016 Sep;17(5):e121-e129. doi: 10.1016/j.cllc.2016.01.003.

PMID: 26898325

 

A practical approach for the scale-up of roller compaction process.

Shi W, Sprockel OL.

Eur J Pharm Biopharm. 2016 Sep;106:15-9. doi: 10.1016/j.ejpb.2016.02.005.

PMID: 26883853

 

 Daclatasvir/peginterferon lambda-1a/ribavirin in patients with chronic HCV infection and haemophilia who are treatment naïve or prior relapsers to peginterferon alfa-2a/ribavirin.

Santagostino E, Pol S, Olveira A, Reesink HW, van Erpecum K, Bogomolov P, Xu D, Critelli L, Srinivasan S, Cooney E.

Haemophilia. 2016 Sep;22(5):692-9. doi: 10.1111/hae.12947.

PMID: 27339614

 

Entecavir plus tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure.

Zoulim F, Białkowska-Warzecha J, Diculescu MM, Goldis AE, Heyne R, Mach T, Marcellin P, Petersen J, Simon K, Bendahmane S, Klauck I, Wasiak W, Janssen HL.

Hepatol Int. 2016 Sep;10(5):779-88. doi: 10.1007/s12072-016-9737-2.

PMID: 27206517

 

Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: a "real-world" observational study in the United States.

Lip GY, Pan X, Kamble S, Kawabata H, Mardekian J, Masseria C, Bruno A, Phatak H.

Int J Clin Pract. 2016 Sep;70(9):752-63. doi: 10.1111/ijcp.12863.

PMID: 27550177

 

 Effect of rate of pyrolysis on the textural properties of naturally-templated porous carbons from alginic acid.

Marriott AS, Hunt AJ, Bergström E, Thomas-Oates J, Clark JH.

J Anal Appl Pyrolysis. 2016 Sep;121:62-66.

PMID: 27695151

 

Development of a Human Whole Blood Screening Platform to Monitor JAK/STAT Signaling Using High-Throughput Flow Cytometry.

Fereshteh MP, Li X, Li S, Fan Y, Zhang R, Farr GA, Kolodin G, Lippy J, Naglich JG, Schieven G, Schweizer L, Zhang L.

J Biomol Screen. 2016 Sep;21(8):866-74. doi: 10.1177/1087057116645095.

PMID: 27142718

 

Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.

Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD.

J Clin Oncol. 2016 Sep 1;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929.

PMID: 27354485

 

Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.

Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S.

J Clin Oncol. 2016 Sep 1;34(25):2969-79. doi: 10.1200/JCO.2016.66.9861.

PMID: 27354481

 

Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective.

Tucker G, DeSilva B, Dressman J, Ito M, Kumamoto T, Mager D, Mahler HC, Maitland-van der Zee AH, Pauletti GM, Sasaki H, Shah V, Tang D, Ward M.

J Pharm Sci. 2016 Sep;105(9):2489-97. doi: 10.1016/j.xphs.2015.12.001.

PMID: 26886325

 

Inhibition of AAK1 Kinase as a Novel Therapeutic Approach to Treat Neuropathic Pain.

Kostich W, Hamman BD, Li YW, Naidu S, Dandapani K, Feng J, Easton A, Bourin C, Baker K, Allen J, Savelieva K, Louis JV, Dokania M, Elavazhagan S, Vattikundala P, Sharma V, Das ML, Shankar G, Kumar A, Holenarsipur VK, Gulianello M, Molski T, Brown JM, Lewis M, Huang Y, Lu Y, Pieschl R, O'Malley K, Lippy J, Nouraldeen A, Lanthorn TH, Ye G, Wilson A, Balakrishnan A, Denton R, Grace JE, Lentz KA, Santone KS, Bi Y, Main A, Swaffield J, Carson K, Mandlekar S, Vikramadithyan RK, Nara SJ, Dzierba C, Bronson J, Macor JE, Zaczek R, Westphal R, Kiss L, Bristow L, Conway CM, Zambrowicz B, Albright CF.

J Pharmacol Exp Ther. 2016 Sep;358(3):371-86. doi: 10.1124/jpet.116.235333.

PMID: 27411717

 

Coproporphyrins in Plasma and Urine Can Be Appropriate Clinical Biomarkers to Recapitulate Drug-Drug Interactions Mediated by Organic Anion Transporting Polypeptide Inhibition.

Lai Y, Mandlekar S, Shen H, Holenarsipur VK, Langish R, Rajanna P, Murugesan S, Gaud N, Selvam S, Date O, Cheng Y, Shipkova P, Dai J, Humphreys WG, Marathe P.

J Pharmacol Exp Ther. 2016 Sep;358(3):397-404. doi: 10.1124/jpet.116.234914.

PMID: 27317801

 

Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine: A Secondary Analysis of a Randomized Clinical Trial.

Alexander JH, Andersson U, Lopes RD, Hijazi Z, Hohnloser SH, Ezekowitz JA, Halvorsen S, Hanna M, Commerford P, Ruzyllo W, Huber K, Al-Khatib SM, Granger CB, Wallentin L; Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators..

JAMA Cardiol. 2016 Sep 1;1(6):673-81. doi: 10.1001/jamacardio.2016.1829.

PMID: 27463942

 

Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial.

George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI.

JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.

PMID: 27243803

 

Nivolumab for classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial.

Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, Armand P, Fanale M, Ratanatharathorn V, Kuruvilla J, Cohen JB, Collins G, Savage KJ, Trneny M, Kato K, Farsaci B, Parker SM, Rodig S, Roemer MG, Ligon AH, Engert A.

Lancet Oncol. 2016 Sep;17(9):1283-94. doi: 10.1016/S1470-2045(16)30167-X.

PMID: 27451390

 

Bioanalysis of dried saliva spot (DSS) samples using detergent-assisted sample extraction with UHPLC-MS/MS detection.

Zheng N, Zeng J, Ji QC, Angeles A, Aubry AF, Basdeo S, Buzescu A, Landry IS, Jariwala N, Turley W, Burrell R, Arnold ME.

Anal Chim Acta. 2016 Aug 31;934:170-9. doi: 10.1016/j.aca.2016.05.057.

PMID: 27506357

 

Harmonizing Global Biospecimen Consent Practices to Advance Translational Research: A Call to Action.

Warner AW, Moore H, Reinhard D, Ball LA, Knoppers BM.

Clin Pharmacol Ther. 2016 Aug 25. doi: 10.1002/cpt.461. [Epub ahead of print]

PMID: 27558027

 

Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors.

Agrawal S, Statkevich P, Bajaj G, Feng Y, Saeger S, Desai DD, Park JS, Waxman IM, Roy A, Gupta M.

J Clin Pharmacol. 2016 Aug 25. doi: 10.1002/jcph.818. [Epub ahead of print]

PMID: 27557786

 

2015 Philip S. Portoghese Medicinal Chemistry Lectureship. Curing Hepatitis C Virus Infection with Direct-Acting Antiviral Agents: The Arc of a Medicinal Chemistry Triumph.

Meanwell NA.

J Med Chem. 2016 Aug 25;59(16):7311-51. doi: 10.1021/acs.jmedchem.6b00915.

PMID: 27501244

 

IL-31-Driven Skin Remodeling Involves Epidermal Cell Proliferation and Thickening That Lead to Impaired Skin-Barrier Function.

Singh B, Jegga AG, Shanmukhappa KS, Edukulla R, Khurana GH, Medvedovic M, Dillon SR, Madala SK.

PLoS One. 2016 Aug 24;11(8):e0161877. doi: 10.1371/journal.pone.0161877. Erratum in: PLoS One. 2017 Jan 23;12 (1):e0170446.

PMID: 27556734

 

Application of X-ray microtomography for the characterisation of hollow polymer-stabilised spray dried amorphous dispersion particles.

Gamble JF, Terada M, Holzner C, Lavery L, Nicholson SJ, Timmins P, Tobyn M.

Int J Pharm. 2016 Aug 20;510(1):1-8. doi: 10.1016/j.ijpharm.2016.05.051.

PMID: 27262271

  

Insights in understanding aggregate formation and dissociation in cation exchange chromatography for a structurally unstable Fc-fusion protein.

Chen Z, Huang C, Chennamsetty N, Xu X, Li ZJ.

J Chromatogr A. 2016 Aug 19;1460:110-22. doi: 10.1016/j.chroma.2016.07.023.

PMID: 27452990

 

A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3.

Foster GR, Chayama K, Chuang WL, Fainboim H, Farkkila M, Gadano A, Gaeta GB, Hézode C, Inada Y, Heo J, Kumada H, Lu SN, Marcellin P, Moreno C, Roberts SK, Strasser SI, Thompson AJ, Toyota J, Paik SW, Vierling JM, Zignego AL, Cohen D, McPhee F, Wind-Rotolo M, Srinivasan S, Hruska M, Myler H, Portsmouth SD.

Springerplus. 2016 Aug 19;5(1):1365. doi: 10.1186/s40064-016-2920-z.

PMID: 27588258

 

Phase II study of vemurafenib followed by ipilimumab in patients with previously untreated BRAF-mutated metastatic melanoma.

Amin A, Lawson DH, Salama AK, Koon HB, Guthrie T Jr, Thomas SS, O'Day SJ, Shaheen MF, Zhang B, Francis S, Hodi FS.

J Immunother Cancer. 2016 Aug 16;4:44. doi: 10.1186/s40425-016-0148-7.

PMID: 27532019

 

Predictive ability of HAS-BLED, HEMORR2HAGES, and ATRIA bleeding risk scores in patients with atrial fibrillation. A French nationwide cross-sectional study.

Fauchier L, Chaize G, Gaudin AF, Vainchtock A, Rushton-Smith SK, Cotté FE.

Int J Cardiol. 2016 Aug 15;217:85-91. doi: 10.1016/j.ijcard.2016.04.173.

PMID: 27179213

 

Characterization of Aggregation Propensity of a Human Fc-Fusion Protein Therapeutic by Hydrogen/Deuterium Exchange Mass Spectrometry.

Huang RY, Iacob RE, Krystek SR, Jin M, Wei H, Tao L, Das TK, Tymiak AA, Engen JR, Chen G.

J Am Soc Mass Spectrom. 2016 Aug 15. [Epub ahead of print]

PMID: 27527097

 

Development of a high-throughput mass spectrometry based analytical method to support an in vitro OATP1B1 inhibition screening assay.

Wagner AD, Elkin L, Mosure K, Gallagher L, Stavola LK, Soars MG, Shou W.

Rapid Commun Mass Spectrom. 2016 Aug 15;30(15):1787-96. doi: 10.1002/rcm.7655.

PMID: 27426455

 

Discovery of a Highly Potent, Selective, and Orally Bioavailable Macrocyclic Inhibitor of Blood Coagulation Factor VIIa-Tissue Factor Complex.

Zhang X, Glunz PW, Johnson JA, Jiang W, Jacutin-Porte S, Ladziata V, Zou Y, Phillips MS, Wurtz NR, Parkhurst B, Rendina AR, Harper TM, Cheney DL, Luettgen JM, Wong PC, Seiffert D, Wexler RR, Priestley ES.

J Med Chem. 2016 Aug 11;59(15):7125-37. doi: 10.1021/acs.jmedchem.6b00469.

PMID: 27455395

 

Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study.

Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J.

J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789.

PMID: 27269947

 

Serum microRNAs-217 and -375 as biomarkers of acute pancreatic injury in rats.

Calvano J, Edwards G, Hixson C, Burr H, Mangipudy R, Tirmenstein M.

Toxicology. 2016 Aug 10;368-369:1-9. doi: 10.1016/j.tox.2016.08.009.

PMID: 27521901

 

Loss of Function of GALNT2 Lowers High-Density Lipoproteins in Humans, Nonhuman Primates, and Rodents.

Khetarpal SA, Schjoldager KT, Christoffersen C, Raghavan A, Edmondson AC, Reutter HM, Ahmed B, Ouazzani R, Peloso GM, Vitali C, Zhao W, Somasundara AV, Millar JS, Park Y, Fernando G, Livanov V, Choi S, Noé E, Patel P, Ho SP; Myocardial Infarction Exome Sequencing Study., Kirchgessner TG, Wandall HH, Hansen L, Bennett EP, Vakhrushev SY, Saleheen D, Kathiresan S, Brown CD, Abou Jamra R, LeGuern E, Clausen H, Rader DJ.

Cell Metab. 2016 Aug 9;24(2):234-45. doi: 10.1016/j.cmet.2016.07.012.

PMID: 27508872

 

Beneficial and Adverse Effects of an LXR Agonist on Human Lipid and Lipoprotein Metabolism and Circulating Neutrophils.

Kirchgessner TG, Sleph P, Ostrowski J, Lupisella J, Ryan CS, Liu X, Fernando G, Grimm D, Shipkova P, Zhang R, Garcia R, Zhu J, He A, Malone H, Martin R, Behnia K, Wang Z, Barrett YC, Garmise RJ, Yuan L, Zhang J, Gandhi MD, Wastall P, Li T, Du S, Salvador L, Mohan R, Cantor GH, Kick E, Lee J, Frost RJ.

Cell Metab. 2016 Aug 9;24(2):223-33. doi: 10.1016/j.cmet.2016.07.016.

PMID: 27508871

 

Daclatasvir/asunaprevir/beclabuvir fixed-dose combination in Japanese patients with HCV genotype 1 infection.

Toyota J, Karino Y, Suzuki F, Ikeda F, Ido A, Tanaka K, Takaguchi K, Naganuma A, Tomita E, Chayama K, Fujiyama S, Inada Y, Yoshiji H, Watanabe H, Ishikawa H, Hu W, McPhee F, Linaberry M, Yin PD, Swenson ES, Kumada H.

J Gastroenterol. 2016 Aug 9. [Epub ahead of print]

PMID: 27502287

 

Nickel-Catalyzed Cross-Coupling of Redox-Active Esters with Boronic Acids.

Wang J, Qin T, Chen TG, Wimmer L, Edwards JT, Cornella J, Vokits B, Shaw SA, Baran PS.

Angew Chem Int Ed Engl. 2016 Aug 8;55(33):9676-9. doi: 10.1002/anie.201605463.

PMID: 27380912

 

Comprehensive evaluation of liver microsomal cytochrome P450 3A (CYP3A) inhibition: comparison of cynomolgus monkey and human.

Haarhoff ZE, Kramer MA, Zvyaga TA, Zhang J, Bhutani P, Subramanian M, Rodrigues AD.

Xenobiotica. 2016 Aug 8:1-9. [Epub ahead of print]

PMID: 27498589

 

In vitro model systems to investigate bile salt export pump (BSEP) activity and drug interactions: A review.

Cheng Y, Woolf TF, Gan J, He K.

Chem Biol Interact. 2016 Aug 5;255:23-30. doi: 10.1016/j.cbi.2015.11.029. Review.

PMID: 26683212

 

A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis.

Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL.

BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.

PMID: 27480410

 

Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.

Chen W, Desai D, Good D, Crison J, Timmins P, Paruchuri S, Wang J, Ha K.

AAPS PharmSciTech. 2016 Aug;17(4):1007-13. doi: 10.1208/s12249-015-0423-9.

PMID: 26729531

 

Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis.

Peterfy C, Burmester GR, Bykerk VP, Combe BG, DiCarlo JC, Furst DE, Huizinga TW, Wong DA, Conaghan PG, Emery P.

Ann Rheum Dis. 2016 Aug;75(8):1501-5. doi: 10.1136/annrheumdis-2015-208258.

PMID: 26865601

 

Recent developments in software tools for high-throughput in vitro ADME support with high-resolution MS.

Paiva A, Shou WZ.

Bioanalysis. 2016 Aug;8(16):1723-33. doi: 10.4155/bio-2016-0074. Review.

PMID: 27487387

 

Quantification of in vivo site-specific Asp isomerization and Asn deamidation of mAbs in animal serum using IP-LC-MS.

Mehl JT, Sleczka BG, Ciccimaro EF, Kozhich AT, Gilbertson DG, Vuppugalla R, Huang CS, Stevens B, Mo J, Deyanova EG, Wang Y, Huang RY, Chen G, Olah TV.

Bioanalysis. 2016 Aug;8(15):1611-1622.

PMID: 27397670

 

Immunoaffinity-coupled MS: best of both technologies.

DeSilva B.

Bioanalysis. 2016 Aug;8(15):1543-1544. No abstract available.

PMID: 27396588

 

Modelling Comparative Efficacy of Drugs with Different Survival Profiles: Ipilimumab, Vemurafenib and Dacarbazine in Advanced Melanoma.

Lee D, Porter J, Hertel N, Hatswell AJ, Briggs A.

BioDrugs. 2016 Aug;30(4):307-19. doi: 10.1007/s40259-016-0178-1.

PMID: 27177756

 

Identifying and retargeting transcriptional hot spots in the human genome.

Cheng JK, Lewis AM, Kim do S, Dyess T, Alper HS.

Biotechnol J. 2016 Aug;11(8):1100-9. doi: 10.1002/biot.201600015.

PMID: 27311394

 

Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study.

Vakkalagadda B, Lubin S, Reynolds L, Liang D, Marion AS, LaCreta F, Boulton DW.

Clin Ther. 2016 Aug;38(8):1890-9. doi: 10.1016/j.clinthera.2016.07.005.

PMID: 27491280

 

Cost-effectiveness of pazopanib compared with sunitinib in metastatic renal cell carcinoma in Canada.

Amdahl J, Diaz J, Park J, Nakhaipour HR, Delea TE.

Curr Oncol. 2016 Aug;23(4):e340-54. doi: 10.3747/co.23.2244.

PMID: 27536183

 

Application of Static Models to Predict Midazolam Clinical Interactions in the Presence of Single or Multiple Hepatitis C Virus Drugs.

Cheng Y, Ma L, Chang SY, Humphreys WG, Li W.

Drug Metab Dispos. 2016 Aug;44(8):1372-80. doi: 10.1124/dmd.116.070409.

PMID: 27226352

 

Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective.

Bohnert T, Patel A, Templeton I, Chen Y, Lu C, Lai G, Leung L, Tse S, Einolf HJ, Wang YH, Sinz M, Stearns R, Walsky R, Geng W, Sudsakorn S, Moore D, He L, Wahlstrom J, Keirns J, Narayanan R, Lang D, Yang X; International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Victim Drug-Drug Interactions Working Group..

Drug Metab Dispos. 2016 Aug;44(8):1399-423. doi: 10.1124/dmd.115.069096.

PMID: 27052879

 

Metabolic characterization of AH-7921, a synthetic opioid designer drug: in vitro metabolic stability assessment and metabolite identification, evaluation of in silico prediction, and in vivo confirmation.

Wohlfarth A, Scheidweiler KB, Pang S, Zhu M, Castaneto M, Kronstrand R, Huestis MA.

Drug Test Anal. 2016 Aug;8(8):779-91. doi: 10.1002/dta.1856.

PMID: 26331297

 

New Directions For Foundations In Health Equity.

Doykos P, Gray-Akpa K, Mitchell F.

Health Aff (Millwood). 2016 Aug 1;35(8):1536-40. doi: 10.1377/hlthaff.2016.0256.

PMID: 27503980

 

Reply.

Miller V, Harrington P, Howe A, Kieffer T, Lennerstrand J, Lenz O, Lontok E, McPhee F, Mo H, Parkin N, Pilot-Matias T.

Hepatology. 2016 Aug;64(2):698-9. doi: 10.1002/hep.28615. No abstract available.

PMID: 27113118

 

The pruritus- and TH2-associated cytokine IL-31 promotes growth of sensory nerves.

Feld M, Garcia R, Buddenkotte J, Katayama S, Lewis K, Muirhead G, Hevezi P, Plesser K, Schrumpf H, Krjutskov K, Sergeeva O, Müller HW, Tsoka S, Kere J, Dillon SR, Steinhoff M, Homey B.

J Allergy Clin Immunol. 2016 Aug;138(2):500-508.e24. doi: 10.1016/j.jaci.2016.02.020.

PMID: 27212086

 

Comparison of Demographic and Clinical Characteristics of Hispanic and Asian Chronic Hepatitis B Patients in Southern California.

Zhu J, Khemichian S, Nghiem D, Zhang SR, Limurti J, Saito T, Fong TL.

J Clin Gastroenterol. 2016 Aug;50(7):602-7. doi: 10.1097/MCG.0000000000000486.

PMID: 26890328

 

Opening New Frontiers in the Development of Life Sciences Technology with Collaborative 3D Printing Technology.

Gill JM 2nd, Hart AS.

J Lab Autom. 2016 Aug;21(4):487-8. doi: 10.1177/2211068216647323. No abstract available.

PMID: 27422022

 

Comparison of hospital length of stay and hospitalization costs among patients with non-valvular atrial fibrillation treated with apixaban or warfarin: An early view.

Xie L, Vo L, Keshishian A, Price K, Singh P, Mardekian J, Bruno A, Baser O, Kim J, Tan W, Trocio J.

J Med Econ. 2016 Aug;19(8):769-76. doi: 10.3111/13696998.2016.1171774.

PMID: 27028360

 

Association of Autoimmune Encephalitis With Combined Immune Checkpoint Inhibitor Treatment for Metastatic Cancer.

Williams TJ, Benavides DR, Patrice KA, Dalmau JO, de Ávila AL, Le DT, Lipson EJ, Probasco JC, Mowry EM.

JAMA Neurol. 2016 Aug 1;73(8):928-33. doi: 10.1001/jamaneurol.2016.1399.

PMID: 27271951

 

Sodium Lauryl Sulfate Competitively Interacts with HPMC-AS and Consequently Reduces Oral Bioavailability of Posaconazole/HPMC-AS Amorphous Solid Dispersion.

Chen Y, Wang S, Wang S, Liu C, Su C, Hageman M, Hussain M, Haskell R, Stefanski K, Qian F.

Mol Pharm. 2016 Aug 1;13(8):2787-95. doi: 10.1021/acs.molpharmaceut.6b00391.

PMID: 27337060

 

40 Hz Auditory Steady-State Response Is a Pharmacodynamic Biomarker for Cortical NMDA Receptors.

Sivarao DV, Chen P, Senapati A, Yang Y, Fernandes A, Benitex Y, Whiterock V, Li YW, Ahlijanian MK.

Neuropsychopharmacology. 2016 Aug;41(9):2232-40. doi: 10.1038/npp.2016.17.

PMID: 26837462

 

Special endpoint and product specific considerations in pharmaceutical acceptable daily exposure derivation.

Gould J, Callis CM, Dolan DG, Stanard B, Weideman PA.

Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S79-93. doi: 10.1016/j.yrtph.2016.05.022.

PMID: 27233924

 

The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future.

Sargent EV, Flueckiger A, Barle EL, Luo W, Molnar LR, Sandhu R, Weideman PA.

Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S3-S10. doi: 10.1016/j.yrtph.2016.05.029.

PMID: 27230736

 

Advances in mechanistic understanding of release rate control mechanisms of extended-release hydrophilic matrix tablets.

Timmins P, Desai D, Chen W, Wray P, Brown J, Hanley S.

Ther Deliv. 2016 Aug;7(8):553-72. doi: 10.4155/tde-2016-0026.

PMID: 27444495

 

Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.

Halpern WG, Ameri M, Bowman CJ, Elwell MR, Mirsky ML, Oliver J, Regan KS, Remick AK, Sutherland VL, Thompson KE, Tremblay C, Yoshida M, Tomlinson L.

Toxicol Pathol. 2016 Aug;44(6):789-809. doi: 10.1177/0192623316650052.

PMID: 27235322

 

Molecular perspective of antibody aggregates and their adsorption on Protein A resin.

Yu D, Song Y, Huang RY, Swanson RK, Tan Z, Schutsky E, Lewandowski A, Chen G, Li ZJ.

J Chromatogr A. 2016 Jul 29;1457:66-75. doi: 10.1016/j.chroma.2016.06.031.

PMID: 27344283

 

A Landscape of Pharmacogenomic Interactions in Cancer.

Iorio F, Knijnenburg TA, Vis DJ, Bignell GR, Menden MP, Schubert M, Aben N, Gonçalves E, Barthorpe S, Lightfoot H, Cokelaer T, Greninger P, van Dyk E, Chang H, de Silva H, Heyn H, Deng X, Egan RK, Liu Q, Mironenko T, Mitropoulos X, Richardson L, Wang J, Zhang T, Moran S, Sayols S, Soleimani M, Tamborero D, Lopez-Bigas N, Ross-Macdonald P, Esteller M, Gray NS, Haber DA, Stratton MR, Benes CH, Wessels LF, Saez-Rodriguez J, McDermott U, Garnett MJ.

Cell. 2016 Jul 28;166(3):740-54. doi: 10.1016/j.cell.2016.06.017.

PMID: 27397505

 

 The Novel, Nicotinic Alpha7 Receptor Partial Agonist, BMS-933043, Improves Cognition and Sensory Processing in Preclinical Models of Schizophrenia.

Bristow LJ, Easton AE, Li YW, Sivarao DV, Lidge R, Jones KM, Post-Munson D, Daly C, Lodge NJ, Gallagher L, Molski T, Pieschl R, Chen P, Hendricson A, Westphal R, Cook J, Iwuagwu C, Morgan D, Benitex Y, King D, Macor JE, Zaczek R, Olson R.

PLoS One. 2016 Jul 28;11(7):e0159996. doi: 10.1371/journal.pone.0159996.

PMID: 27467081

 

Ligand-Promoted Meta-C-H Arylation of Anilines, Phenols, and Heterocycles.

Wang P, Farmer ME, Huo X, Jain P, Shen PX, Ishoey M, Bradner JE, Wisniewski SR, Eastgate MD, Yu JQ.

J Am Chem Soc. 2016 Jul 27;138(29):9269-76. doi: 10.1021/jacs.6b04966.

PMID:

 

(19) F NMR Spectroscopy as a Highly Sensitive Method for the Direct Monitoring of Confined Crystallization within Nanoporous Materials.

Nartowski KP, Malhotra D, Hawarden LE, Sibik J, Iuga D, Zeitler JA, Fábián L, Khimyak YZ.

Angew Chem Int Ed Engl. 2016 Jul 25;55(31):8904-8. doi: 10.1002/anie.201602936.

PMID: 27272008

 

Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer.

Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D.

J Clin Oncol. 2016 Jul 25. pii: JCO676601. [Epub ahead of print]

PMID: 27458307

 

No clinically significant pharmacokinetic interactions between dolutegravir and daclatasvir in healthy adult subjects.

Ross LL, Song IH, Arya N, Choukour M, Zong J, Huang SP, Eley T, Wynne B, Buchanan AM.

BMC Infect Dis. 2016 Jul 22;16:347. doi: 10.1186/s12879-016-1629-5.

PMID: 27450277

 

Functional Antagonism of Human CD40 Achieved by Targeting a Unique Species-Specific Epitope.

Yamniuk AP, Suri A, Krystek SR, Tamura J, Ramamurthy V, Kuhn R, Carroll K, Fleener C, Ryseck R, Cheng L, An Y, Drew P, Grant S, Suchard SJ, Nadler SG, Bryson JW, Sheriff S.

J Mol Biol. 2016 Jul 17;428(14):2860-79. doi: 10.1016/j.jmb.2016.05.014.

PMID: 27216500

 

Discovery of hydroxyl 1,2-diphenylethanamine analogs as potent cholesterol ester transfer protein inhibitors.

Jiang J, Finlay H, Johnson JA, Harikrishnan L, Kamau M, Qiao J, Wang T, Adam L, Taylor D, Yang R, Sleph P, Chen AY, Yin X, Wexler R, Salvati ME.

Bioorg Med Chem Lett. 2016 Jul 15;26(14):3278-81. doi: 10.1016/j.bmcl.2016.05.058.

PMID: 27256912

 

Exploitation of the size-exclusion effect of reversed-phase high performance liquid chromatography for the direct analysis of diethylene triamine pentaacetic acid in therapeutic monoclonal antibody formulations.

Huang JZ, Liao K, Wang G, Haby T, Bolgar MS.

J Chromatogr A. 2016 Jul 15;1455:140-6. doi: 10.1016/j.chroma.2016.05.087.

PMID: 27295965

 

Chromatography-based methods for determining molar extinction coefficients of cytotoxic payload drugs and drug antibody ratios of antibody drug conjugates.

Wang C, Chen S, Caceres-Cortes J, Huang RY, Tymiak AA, Zhang Y.

J Chromatogr A. 2016 Jul 15;1455:133-9. doi: 10.1016/j.chroma.2016.05.086.

PMID: 27286648

 

Discovery and Structure-Activity Relationship (SAR) of a Series of Ethanolamine-Based Direct-Acting Agonists of Sphingosine-1-phosphate (S1P1).

Gilmore JL, Sheppeck JE 2nd, Watterson SH, Haque L, Mukhopadhyay P, Tebben AJ, Galella MA, Shen DR, Yarde M, Cvijic ME, Borowski V, Gillooly K, Taylor T, McIntyre KW, Warrack B, Levesque PC, Li JP, Cornelius G, D'Arienzo C, Marino A, Balimane P, Salter-Cid L, Barrish JC, Pitts WJ, Carter PH, Xie J, Dyckman AJ.

J Med Chem. 2016 Jul 14;59(13):6248-64. doi: 10.1021/acs.jmedchem.6b00373.

PMID: 27309907

 

Coarse-Grained Antibody Models for "Weak" Protein-Protein Interactions from Low to High Concentrations.

Calero-Rubio C, Saluja A, Roberts CJ.

J Phys Chem B. 2016 Jul 14;120(27):6592-605. doi: 10.1021/acs.jpcb.6b04907.

PMID: 27314827

 

Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.

Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boqué C, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A.

J Clin Oncol. 2016 Jul 10;34(20):2333-40. doi: 10.1200/JCO.2015.64.8899.

PMID: 27217448

 

Streamlined Total Synthesis of Uncialamycin and Its Application to the Synthesis of Designed Analogues for Biological Investigations.

Nicolaou KC, Wang Y, Lu M, Mandal D, Pattanayak MR, Yu R, Shah AA, Chen JS, Zhang H, Crawford JJ, Pasunoori L, Poudel YB, Chowdari NS, Pan C, Nazeer A, Gangwar S, Vite G, Pitsinos EN.

J Am Chem Soc. 2016 Jul 6;138(26):8235-46. doi: 10.1021/jacs.6b04339.

PMID: 27266267

 

Exclusion of Dlx5/6 expression from the distal-most mandibular arches enables BMP-mediated specification of the distal cap.

Vincentz JW, Casasnovas JJ, Barnes RM, Que J, Clouthier DE, Wang J, Firulli AB.

Proc Natl Acad Sci U S A. 2016 Jul 5;113(27):7563-8. doi: 10.1073/pnas.1603930113.

PMID: 27335460

 

Sex differences and hormonal effects on gut microbiota composition in mice.

Org E, Mehrabian M, Parks BW, Shipkova P, Liu X, Drake TA, Lusis AJ.

Gut Microbes. 2016 Jul 3;7(4):313-322.

PMID: 27355107

 

Development and Validation of Electrochemiluminescence Assays to Measure Free and Total sSLAMF7 in Human Serum in the Absence and Presence of Elotuzumab.

Postelnek J, Neely RJ, Robbins MD, Gleason CR, Peterson JE, Piccoli SP.

AAPS J. 2016 Jul;18(4):989-99. doi: 10.1208/s12248-016-9912-3.

PMID: 27116021

 

Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir.

Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F.

Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1.

PMID: 27287851

 

A Comprehensive Overview of Direct Oral Anticoagulants for the Management of Venous Thromboembolism.

Comerota AJ, Ramacciotti E.

Am J Med Sci. 2016 Jul;352(1):92-106. doi: 10.1016/j.amjms.2016.03.018. Review.

PMID: 27432042

 

Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

Manolakopoulos S, Zacharakis G, Zissis M, Giannakopoulos V.

Ann Gastroenterol. 2016 Jul-Sep;29(3):282-96. doi: 10.20524/aog.2016.0041. Review.

PMID: 27366028

 

Designing proteins to combat disease: Cardiac troponin C as an example.

Davis JP, Shettigar V, Tikunova SB, Little SC, Liu B, Siddiqui JK, Janssen PM, Ziolo MT, Walton SD.

Arch Biochem Biophys. 2016 Jul 1;601:4-10. doi: 10.1016/j.abb.2016.02.007.

PMID: 26901433

 

Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis.

Fleischmann R, Weinblatt ME, Schiff M, Khanna D, Maldonado MA, Nadkarni A, Furst DE.

Arthritis Care Res (Hoboken). 2016 Jul;68(7):907-13. doi: 10.1002/acr.22763.

PMID: 26473625

 

Antibody-drug conjugate bioanalysis using LB-LC-MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays.

Wang J, Gu H, Liu A, Kozhich A, Rangan V, Myler H, Luo L, Wong R, Sun H, Wang B, Vezina HE, Deshpande S, Zhang Y, Yang Z, Olah TV, Aubry AF, Arnold ME, Pillutla R, DeSilva B.

Bioanalysis. 2016 Jul;8(13):1383-401. doi: 10.4155/bio-2016-0017.

PMID: 27277879

 

Biliary excretion of pravastatin and taurocholate in rats with bile salt export pump (Bsep) impairment.

Cheng Y, Freeden C, Zhang Y, Abraham P, Shen H, Wescott D, Humphreys WG, Gan J, Lai Y.

Biopharm Drug Dispos. 2016 Jul;37(5):276-86. doi: 10.1002/bdd.2011.

PMID: 27059119

 

Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study.

Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP.

Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717.

PMID: 27118102

 

In Situ Tumor Vaccination by Combining Local Radiation and Tumor-Specific Antibody or Immunocytokine Treatments.

Morris ZS, Guy EI, Francis DM, Gressett MM, Werner LR, Carmichael LL, Yang RK, Armstrong EA, Huang S, Navid F, Gillies SD, Korman A, Hank JA, Rakhmilevich AL, Harari PM, Sondel PM.

Cancer Res. 2016 Jul 1;76(13):3929-41. doi: 10.1158/0008-5472.CAN-15-2644.

PMID: 27197149

 

Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy.

Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ.

Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980.

PMID: 26589105

 

Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.

Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C.

Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004.

PMID: 27292282

 

Pharmacokinetics and pharmacodynamics of dapagliflozin in children and adolescents with type 2 diabetes mellitus.

Tirucherai GS, LaCreta F, Ismat FA, Tang W, Boulton DW.

Diabetes Obes Metab. 2016 Jul;18(7):678-84. doi: 10.1111/dom.12638.

PMID: 27291448

 

Long-Term Safety of Dapagliflozin in Older Patients with Type 2 Diabetes Mellitus: A Pooled Analysis of Phase IIb/III Studies.

Fioretto P, Mansfield TA, Ptaszynska A, Yavin Y, Johnsson E, Parikh S.

Drugs Aging. 2016 Jul;33(7):511-22. doi: 10.1007/s40266-016-0382-1.

PMID: 27357173

 

Implementation of mechanism of action biology-driven early drug development for children with cancer.

Pearson AD, Herold R, Rousseau R, Copland C, Bradley-Garelik B, Binner D, Capdeville R, Caron H, Carleer J, Chesler L, Geoerger B, Kearns P, Marshall LV, Pfister SM, Schleiermacher G, Skolnik J, Spadoni C, Sterba J, van den Berg H, Uttenreuther-Fischer M, Witt O, Norga K, Vassal G; Members of Working Group 1 of the Paediatric Platform of ACCELERATE..

Eur J Cancer. 2016 Jul;62:124-31. doi: 10.1016/j.ejca.2016.04.001.

PMID: 27258969

 

RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.

Schwartz LH, Seymour L, Litière S, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, de Vries E.

Eur J Cancer. 2016 Jul;62:138-45. doi: 10.1016/j.ejca.2016.03.082.

PMID: 27237360

 

RECIST 1.1-Update and clarification: From the RECIST committee.

Schwartz LH, Litière S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L.

Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081.

PMID: 27189322

  

Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease.

Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG.

Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973.

PMID: 25935574

 

384-Well Multiplexed Luminex Cytokine Assays for Lead Optimization.

Tang H, Panemangalore R, Yarde M, Zhang L, Cvijic ME.

J Biomol Screen. 2016 Jul;21(6):548-55. doi: 10.1177/1087057116644164.

PMID: 27095819

 

Robust Translation of γ-Secretase Modulator Pharmacology across Preclinical Species and Human Subjects.

Toyn JH, Boy KM, Raybon J, Meredith JE Jr, Robertson AS, Guss V, Hoque N, Sweeney F, Zhuo X, Clarke W, Snow K, Denton RR, Zuev D, Thompson LA, Morrison J, Grace J, Berisha F, Furlong M, Wang JS, Lentz KA, Padmanabha R, Cook L, Wei C, Drexler DM, Macor JE, Albright CF, Gasior M, Olson RE, Hong Q, Soares HD, AbuTarif M, Ahlijanian MK.

J Pharmacol Exp Ther. 2016 Jul;358(1):125-37. doi: 10.1124/jpet.116.232249.

PMID: 27189974

 

The γ-Secretase Modulator, BMS-932481, Modulates Aβ Peptides in the Plasma and Cerebrospinal Fluid of Healthy Volunteers.

Soares HD, Gasior M, Toyn JH, Wang JS, Hong Q, Berisha F, Furlong MT, Raybon J, Lentz KA, Sweeney F, Zheng N, Akinsanya B, Berman RM, Thompson LA, Olson RE, Morrison J, Drexler DM, Macor JE, Albright CF, Ahlijanian MK, AbuTarif M.

J Pharmacol Exp Ther. 2016 Jul;358(1):138-50. doi: 10.1124/jpet.116.232256.

PMID: 27189973

 

Evaluation of cardiac function in unrestrained dogs and monkeys using left ventricular dP/dt.

Buchanan LV, Warner WA, Arthur SR, Gleason CR, Lewen G, Levesque PC, Gill MW.

J Pharmacol Toxicol Methods. 2016 Jul-Aug;80:51-8. doi: 10.1016/j.vascn.2016.03.006.

PMID: 27063376

 

Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial.

Hijazi Z, Hohnloser SH, Andersson U, Alexander JH, Hanna M, Keltai M, Parkhomenko A, López-Sendón JL, Lopes RD, Siegbahn A, Granger CB, Wallentin L.

JAMA Cardiol. 2016 Jul 1;1(4):451-60. doi: 10.1001/jamacardio.2016.1170.

PMID: 27438322

 

Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial.

Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ.

Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5.

PMID: 27283863

 

Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial.

Antonia SJ, López-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jäger D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E.

Lancet Oncol. 2016 Jul;17(7):883-95. doi: 10.1016/S1470-2045(16)30098-5.

PMID: 27269741

 

Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial.

Weber JS, Gibney G, Sullivan RJ, Sosman JA, Slingluff CL Jr, Lawrence DP, Logan TF, Schuchter LM, Nair S, Fecher L, Buchbinder EI, Berghorn E, Ruisi M, Kong G, Jiang J, Horak C, Hodi FS.

Lancet Oncol. 2016 Jul;17(7):943-55. doi: 10.1016/S1470-2045(16)30126-7.

PMID: 27269740

 

Low incidence of peripheral arterial disease in patients receiving dasatinib in clinical trials.

le Coutre PD, Hughes TP, Mahon FX, Kim DW, Steegmann JL, Shah NP, Gooden K, Wallis N, Cortes JE.

Leukemia. 2016 Jul;30(7):1593-6. doi: 10.1038/leu.2015.352. No abstract available.

PMID: 26686247

 

Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.

Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S.

Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049.

PMID: 26683763

 

Detection and quantification of RNA 2'-O-methylation and pseudouridylation.

Huang C, Karijolich J, Yu YT.

Methods. 2016 Jul 1;103:68-76. doi: 10.1016/j.ymeth.2016.02.003.

PMID: 26853326

 

Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis.

Harigai M, Ishiguro N, Inokuma S, Mimori T, Ryu J, Takei S, Takeuchi T, Tanaka Y, Takasaki Y, Yamanaka H, Watanabe M, Tamada H, Koike T.

Mod Rheumatol. 2016 Jul;26(4):491-8. doi: 10.3109/14397595.2015.1123211.

PMID: 26635183

 

Organizational effectiveness: a key to R&D productivity.

Tollman P, Panier V, Dosik D, Biondi P, Cuss F.

Nat Rev Drug Discov. 2016 Jul;15(7):441-2. doi: 10.1038/nrd.2016.91.

PMID: 27312725

 

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

Mathonet S, Mahler HC, Esswein ST, Mazaheri M, Cash PW, Wuchner K, Kallmeyer G, Das TK, Finkler C, Lennard A.

PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):392-408. doi: 10.5731/pdajpst.2015.006189.

PMID: 27091885

 

Effects of antipsychotics on cortisol, interleukin-6 and hippocampal perfusion in healthy volunteers.

Handley R, Mondelli V, Zelaya F, Marques T, Taylor H, Reinders AA, Chaddock C, McQueen G, Hubbard K, Papadopoulos A, Williams S, McGuire P, Pariante C, Dazzan P.

Schizophr Res. 2016 Jul;174(1-3):99-105. doi: 10.1016/j.schres.2016.03.039.

PMID: 27112637

 

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary.

Bueno H, de Graeff P, Richard-Lordereau I, Emmerich J, Fox KA, Friedman CP, Gaudin C, El-Gazayerly A, Goldman S, Hemmrich M, Henderson RA, Himmelmann A, Irs A, Jackson N, James SK, Katus HA, Laslop A, Laws I, Mehran R, Ong S, Prasad K, Roffi M, Rosano GM, Rose M, Sinnaeve PR, Stough WG, Thygesen K, Van de Werf F, Varin C, Verheugt FW, de Los Angeles Alonso García M.

Eur Heart J Acute Cardiovasc Care. 2016 Jun 29. pii: 2048872616649859. [Epub ahead of print]

PMID: 27357206

 

Determination of process variables affecting drug particle attrition withinmulti-component blends during powder feed transmission.

Gamble JF, Dennis AB, Hutchins P, Jones JW, Musembi P, Tobyn M.

Pharm Dev Technol. 2016 Jun 27:1-6. [Epub ahead of print]

PMID: 27344924

 

A Fluorescence-Based High-Throughput Coupled Enzymatic Assay for Quantitation of Isoaspartate in Proteins and Peptides.

Puri A, Quan Y, Narang AS, Adams M, Gandhi R, Nashine VC.

AAPS PharmSciTech. 2016 Jun 24. [Epub ahead of print]

PMID: 27342117

 

Identification and Characterization of BMS-955176, a Second-Generation HIV-1 Maturation Inhibitor with Improved Potency, Antiviral Spectrum, and Gag Polymorphic Coverage.

Nowicka-Sans B, Protack T, Lin Z, Li Z, Zhang S, Sun Y, Samanta H, Terry B, Liu Z, Chen Y, Sin N, Sit SY, Swidorski JJ, Chen J, Venables BL, Healy M, Meanwell NA, Cockett M, Hanumegowda U, Regueiro-Ren A, Krystal M, Dicker IB.

Antimicrob Agents Chemother. 2016 Jun 20;60(7):3956-69. doi: 10.1128/AAC.02560-15.

PMID: 27090171

 

Editorial: The Physiology and Pharmacology of Leucine-rich Repeat GPCRs.

Arey BJ, Dias JA.

Front Endocrinol (Lausanne). 2016 Jun 17;7:56. doi: 10.3389/fendo.2016.00056. No abstract available.

PMID: 27379012

 

B cells from African American lupus patients exhibit an activated phenotype.

Menard LC, Habte S, Gonsiorek W, Lee D, Banas D, Holloway DA, Manjarrez-Orduno N, Cunningham M, Stetsko D, Casano F, Kansal S, Davis PM, Carman J, Zhang CK, Abidi F, Furie R, Nadler SG, Suchard SJ.

JCI Insight. 2016 Jun 16;1(9):e87310.

PMID: 27699274

 

Understanding and Controlling Sialylation in a CHO Fc-Fusion Process.

Lewis AM, Croughan WD, Aranibar N, Lee AG, Warrack B, Abu-Absi NR, Patel R, Drew B, Borys MC, Reily MD, Li ZJ.

PLoS One. 2016 Jun 16;11(6):e0157111. doi: 10.1371/journal.pone.0157111.

PMID: 27310468

 

The utility of stable isotope labeled (SIL) analogues in the bioanalysis of endogenous compounds by LC-MS applied to the study of bile acids in a metabolomics assay.

Zheng JJ, Shields EE, Snow KJ, Nelson DM, Olah TV, Reily MD, Robertson DG, Shipkova PA, Stryker SA, Xin B, Drexler DM.

Anal Biochem. 2016 Jun 15;503:71-8. doi: 10.1016/j.ab.2016.03.011.

PMID: 27033006

 

12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.

Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P.

Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163.

PMID: 27025835

 

Therapeutic Activity of Agonistic, Human Anti-CD40 Monoclonal Antibodies Requires Selective FcγR Engagement.

Dahan R, Barnhart BC, Li F, Yamniuk AP, Korman AJ, Ravetch JV.

Cancer Cell. 2016 Jun 13;29(6):820-31. doi: 10.1016/j.ccell.2016.05.001.

PMID: 27265505

 

ApoE deficiency exacerbates the development and sustainment of a semi-chronic K/BxN serum transfer-induced arthritis model.

Archer AM, Saber R, Rose S, Shaffer A, Misharin AV, Tsai F, Haines Iii GK, Dominguez S, Eren M, Vaughan DE, Cuda CM, Perlman H.

J Transl Med. 2016 Jun 10;14(1):170. doi: 10.1186/s12967-016-0912-y.

PMID: 27287704

 

Discovery of 5-Phenyl-N-(pyridin-2-ylmethyl)-2-(pyrimidin-5-yl)quinazolin-4-amine as a Potent I Kur Inhibitor.

Finlay HJ, Johnson JA, Lloyd JL, Jiang J, Neels J, Gunaga P, Banerjee A, Dhondi N, Chimalakonda A, Mandlekar S, Conder ML, Sale H, Xing D, Levesque P, Wexler RR.

ACS Med Chem Lett. 2016 Jun 9;7(9):831-4. doi: 10.1021/acsmedchemlett.6b00117.

PMID: 27660686

 

Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM.

Jakubowiak A, Offidani M, Pégourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A.

Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604.

PMID: 27091875

 

A Small Molecule Inhibitor Selectively Induces Apoptosis in Cells Transformed by High Risk Human Papilloma Viruses.

Sheaffer AK, Lee MS, Qi H, Chaniewski S, Zheng X, Farr GA, Esposito K, Harden D, Lei M, Schweizer L, Friborg J, Agler M, McPhee F, Gentles R, Beno BR, Chupak L, Mason S.

PLoS One. 2016 Jun 9;11(6):e0155909. doi: 10.1371/journal.pone.0155909.

PMID: 27280728

 

Examining Manufacturing Readiness for Breakthrough Drug Development.

Dye E, Sturgess A, Maheshwari G, May K, Ruegger C, Ramesh U, Tan H, Cockerill K, Groskoph J, Lacana E, Lee S, Miksinski SP.

AAPS PharmSciTech. 2016 Jun;17(3):529-38. doi: 10.1208/s12249-015-0455-1. Review. No abstract available.

PMID: 26608693

 

[Cost-effectiveness analysis of apixaban versus acetylsalicylic acid in the prevention of stroke in patients with non-valvular atrial fibrillation in Spain].

Escolar-Albaladejo G, Barón-Esquivias G, Zamorano JL, Betegón-Nicolás L, Canal-Fontcuberta C, de Salas-Cansado M, Rubio-Rodríguez D, Rubio-Terrés C.

Aten Primaria. 2016 Jun-Jul;48(6):394-405. doi: 10.1016/j.aprim.2015.04.012. Spanish.

PMID: 26832316

 

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy.

Nie L, Rubin EH, Mehrotra N, Pinheiro J, Fernandes LL, Roy A, Bailey S, de Alwis DP.

Clin Cancer Res. 2016 Jun 1;22(11):2623-9. doi: 10.1158/1078-0432.CCR-15-2644.

PMID: 27250933

 

Case report: successful retreatment of hepatitis C genotype 1b infection with sofosbuvir + simeprevir in a patient with cirrhosis who had prior virologic relapse after treatment with daclatasvir and asunaprevir.

Safadi R, Noviello S, Boparai N, McPhee F.

Clin Case Rep. 2016 Jun 1;4(7):653-6. doi: 10.1002/ccr3.581.

PMID: 27386121

 

Cross-Intolerance With Dasatinib Among Imatinib-Intolerant Patients With Chronic Phase Chronic Myeloid Leukemia.

Khoury HJ, Goldberg SL, Mauro MJ, Stone RM, Deininger MW, Bradley-Garelik MB, Mohamed H, Guilhot F.

Clin Lymphoma Myeloma Leuk. 2016 Jun;16(6):341-349.e1. doi: 10.1016/j.clml.2016.03.004.

PMID: 27133948

 

Chronic hepatitis C: Burden of disease and cost associated with hospitalisations in France in 2012 (The HEPC-LONE study).

Abergel A, Rotily M, Branchoux S, Akremi R, de Léotoing L, Vainchtock A, Gaudin AF.

Clin Res Hepatol Gastroenterol. 2016 Jun;40(3):340-8. doi: 10.1016/j.clinre.2015.08.006.

PMID: 26546175

 

Biotransformation of Daclatasvir In Vitro and in Nonclinical Species: Formation of the Main Metabolite by Pyrrolidine δ-Oxidation and Rearrangement.

Li W, Zhao W, Liu X, Huang X, Lopez OD, Leet JE, Fancher RM, Nguyen V, Goodrich J, Easter J, Hong Y, Caceres-Cortes J, Chang SY, Ma L, Belema M, Hamann LG, Gao M, Zhu M, Shu YZ, Humphreys WG, Johnson BM.

Drug Metab Dispos. 2016 Jun;44(6):809-20. doi: 10.1124/dmd.115.068866.

PMID: 27029743

 

An Integrated Approach for Studying Exposure, Metabolism, and Disposition of Multiple Component Herbal Medicines Using High-Resolution Mass Spectrometry and Multiple Data Processing Tools.

Wu C, Zhang H, Wang C, Qin H, Zhu M, Zhang J.

Drug Metab Dispos. 2016 Jun;44(6):800-8. doi: 10.1124/dmd.115.068189.

PMID: 27013399

 

Cancer Treatment with Anti-PD-1/PD-L1 Agents: Is PD-L1 Expression a Biomarker for Patient Selection?

Festino L, Botti G, Lorigan P, Masucci GV, Hipp JD, Horak CE, Melero I, Ascierto PA.

Drugs. 2016 Jun;76(9):925-45. doi: 10.1007/s40265-016-0588-x. Review.

PMID: 27229745

 

Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy.

Gaultney J, Benucci M, Iannazzo S, Nappi C, Sion K, Sabater FJ.

Expert Rev Pharmacoecon Outcomes Res. 2016 Jun;16(3):409-17. doi: 10.1586/14737167.2016.1102636.

PMID: 26495961

 

A validated enantioselective LC-MS/MS assay for quantification of a major chiral metabolite of an achiral 11-β-hydroxysteroid-dehydrogenase 1 inhibitor in human plasma: Application to a clinical pharmacokinetic study.

Furlong MT, Ji QC, Iacono L, Dang O, Noren M, Bruce J, Aubry AF, Arnold ME.

J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Jun 1;1022:167-72. doi: 10.1016/j.jchromb.2016.03.043.

PMID: 27100678

 

Semiautomated Sample Preparation for Protein Stability and Formulation Screening via Buffer Exchange.

Ying W, Levons JK, Carney A, Gandhi R, Vydra V, Rubin AE.

J Lab Autom. 2016 Jun;21(3):378-86. doi: 10.1177/2211068215585484.

PMID: 25969451

 

Economic evaluation of nivolumab for the treatment of second-line advanced squamous NSCLC in Canada: a comparison of modeling approaches to estimate and extrapolate survival outcomes.

Goeree R, Villeneuve J, Goeree J, Penrod JR, Orsini L, Tahami Monfared AA.

J Med Econ. 2016 Jun;19(6):630-44. doi: 10.3111/13696998.2016.1151432.

PMID: 26850122

 

Rates, factors, reasons, and economic impact associated with switching in rheumatoid arthritis patients newly initiated on biologic disease modifying anti-rheumatic drugs in an integrated healthcare system.

Rashid N, Lin AT, Aranda G Jr, Lin KJ, Guerrero VN, Nadkarni A, Patel C.

J Med Econ. 2016 Jun;19(6):568-75. doi: 10.3111/13696998.2016.1142448.

PMID: 26766553

 

Clinical and economic benefits of extended treatment with apixaban for the treatment and prevention of recurrent venous thromboembolism in Canada.

Quon P, Le HH, Raymond V, Mtibaa M, Moshyk A.

J Med Econ. 2016 Jun;19(6):557-67. doi: 10.3111/13696998.2016.1141780.

PMID: 26761644

 

The effect of dapagliflozin on renal function in patients with type 2 diabetes.

Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L.

J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1.

PMID: 26894924

 

Development of a spontaneously active dorsal root ganglia assay using multiwell multielectrode arrays.

Newberry K, Wang S, Hoque N, Kiss L, Ahlijanian MK, Herrington J, Graef JD.

J Neurophysiol. 2016 Jun 1;115(6):3217-28. doi: 10.1152/jn.01122.2015.

PMID: 27052585

 

Correlation of Phosphorus Cross-Linking to Hydration Rates in Sodium Starch Glycolate Tablet Disintegrants Using MRI.

Abraham A, Olusanmi D, Ilott AJ, Good D, Murphy D, Mcnamara D, Jerschow A, Mantri RV.

J Pharm Sci. 2016 Jun;105(6):1907-13. doi: 10.1016/j.xphs.2016.03.025.

PMID: 27155767

 

Model-based pharmacokinetic analysis of elotuzumab in patients with relapsed/refractory multiple myeloma.

Gibiansky L, Passey C, Roy A, Bello A, Gupta M.

J Pharmacokinet Pharmacodyn. 2016 Jun;43(3):243-57. doi: 10.1007/s10928-016-9469-x.

PMID: 26993283

 

The Impact of State AIDS Drug Assistance Policies on Clinical and Economic Outcomes of People With HIV.

Snider JT, Goldman DP, Rosenblatt L, Seekins D, Juday T, Sanchez Y, Wu Y, Peneva D, Romley JA.

Med Care Res Rev. 2016 Jun;73(3):329-48. doi: 10.1177/1077558715614479.

PMID: 26537525

 

Key factors for successful data integration in biomarker research.

Elefsinioti A, Bellaire T, Wang A, Quast K, Seidel H, Braxenthaler M, Goeller G, Christianson A, Henderson D, Reischl J.

Nat Rev Drug Discov. 2016 Jun;15(6):369-70. doi: 10.1038/nrd.2016.74.

PMID: 27173942

 

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity.

Ahlberg E, Amberg A, Beilke LD, Bower D, Cross KP, Custer L, Ford KA, Van Gompel J, Harvey J, Honma M, Jolly R, Joossens E, Kemper RA, Kenyon M, Kruhlak N, Kuhnke L, Leavitt P, Naven R, Neilan C, Quigley DP, Shuey D, Spirkl HP, Stavitskaya L, Teasdale A, White A, Wichard J, Zwickl C, Myatt GJ.

Regul Toxicol Pharmacol. 2016 Jun;77:1-12. doi: 10.1016/j.yrtph.2016.02.003.

PMID: 26879463

 

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses.

Amberg A, Beilke L, Bercu J, Bower D, Brigo A, Cross KP, Custer L, Dobo K, Dowdy E, Ford KA, Glowienke S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Nicolette J, Plaper A, Powley M, Quigley DP, Reddy MV, Spirkl HP, Stavitskaya L, Teasdale A, Weiner S, Welch DS, White A, Wichard J, Myatt GJ.

Regul Toxicol Pharmacol. 2016 Jun;77:13-24. doi: 10.1016/j.yrtph.2016.02.004.

PMID: 26877192

 

Effects of aripiprazole and haloperidol on neural activation during the n-back in healthy individuals: A functional MRI study.

Goozee R, Reinders AA, Handley R, Marques T, Taylor H, O'Daly O, McQueen G, Hubbard K, Mondelli V, Pariante C, Dazzan P.

Schizophr Res. 2016 Jun;173(3):174-81. doi: 10.1016/j.schres.2015.02.023.

PMID: 25778615

 

Physician and Patient Preferences for Nonvalvular Atrial Fibrillation Therapies.

Shafrin J, Bruno A, MacEwan JP, Campinha-Bacote A, Trocio J, Shah M, Tan W, Romley JA.

Value Health. 2016 Jun;19(4):451-9. doi: 10.1016/j.jval.2016.01.001.

PMID: 27325337

 

Impact of menstruation on select hematology and clinical chemistry variables in cynomolgus macaques.

Perigard CJ, Parrula MC, Larkin MH, Gleason CR.

Vet Clin Pathol. 2016 Jun;45(2):232-43. doi: 10.1111/vcp.12350.

PMID: 27061515

 

The syntheses of [(14) C]BMS-823778 for use in a human ADME clinical study and of [(13) CD3 (13) CD2 ]BMT-094817, a stable-isotope labeled standard of a newly detected human metabolite.

Maxwell BD, Tran SB, Lago M, Li J, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 May 30;59(6):255-9. doi: 10.1002/jlcr.3383.

PMID: 27169762

 

Structural characterization of low level degradants in aztreonam injection and an innovative approach to aid HPLC method validation.

Ye Q, Ding W, Rinaldi F, Huang Y, Miller SA, Bolgar M.

J Pharm Biomed Anal. 2016 May 30;124:358-64. doi: 10.1016/j.jpba.2016.03.017.

PMID: 26991056

 

Three strikes and research is out.

Orsini MJ.

Science. 2016 May 27;352(6289):1138. doi: 10.1126/science.352.6289.1138. No abstract available.

PMID: 27230382

 

Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept.

Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC.

BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

PMID: 27229685

 

Population Pharmacokinetics Analysis To Inform Efavirenz Dosing Recommendations in Pediatric HIV Patients Aged 3 Months to 3 Years.

Luo M, Chapel S, Sevinsky H, Savant I, Cirincione B, Bertz R, Roy A.

Antimicrob Agents Chemother. 2016 May 23;60(6):3676-86. doi: 10.1128/AAC.02678-15.

PMID: 27067333

 

The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation.

Hijazi Z, Lindbäck J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators..

Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054.

PMID: 26920728

 

Proposed Mode of Binding and Action of Positive Allosteric Modulators at Opioid Receptors.

Shang Y, Yeatman HR, Provasi D, Alt A, Christopoulos A, Canals M, Filizola M.

ACS Chem Biol. 2016 May 20;11(5):1220-9. doi: 10.1021/acschembio.5b00712.

PMID: 26841170

 

Immunomodulatory antibodies for the treatment of lymphoma: Report on the CALYM Workshop.

Houot R, Gaulard P, Schreiber R, Mellman I, Lambotte O, Coulie PG, Fest T, Korman A, Levy R, Shipp M, Tarte K, Kohrt H, Marabelle A, Ansell S, Watier H, van Elsas A, Balakumaran A, Arce Vargas F, Quezada SA, Salles G, Olive D.

Oncoimmunology. 2016 May 19;5(7):e1186323. doi: 10.1080/2162402X.2016.1186323.

PMID: 27622041

 

Biotechnology Based Process for Production of a Disulfide-Bridged Peptide.

Goswami A, Goldberg SL, Hanson RL, Johnston RM, Lyngberg OK, Chan Y, Lo E, Chan SH, de Mas N, Ramirez A, Doyle R, Ding W, Gao M, Krystek SR Jr, Wan C, Kim YJ, Calambur D, Witmer M, Bryson JW.

Bioconjug Chem. 2016 May 18;27(5):1276-84. doi: 10.1021/acs.bioconjchem.6b00101.

PMID: 27098672

 

Synthesis of Diverse (11)C-Labeled PET Radiotracers via Direct Incorporation of [(11)C]CO2.

Mossine AV, Brooks AF, Jackson IM, Quesada CA, Sherman P, Cole EL, Donnelly DJ, Scott PJ, Shao X.

Bioconjug Chem. 2016 May 18;27(5):1382-9. doi: 10.1021/acs.bioconjchem.6b00163.

PMID: 27043721

 

Agonist anti-GITR monoclonal antibody and stereotactic radiation induce immune-mediated survival advantage in murine intracranial glioma.

Patel MA, Kim JE, Theodros D, Tam A, Velarde E, Kochel CM, Francica B, Nirschl TR, Ghasemzadeh A, Mathios D, Harris-Bookman S, Jackson CC, Jackson C, Ye X, Tran PT, Tyler B, Coric V, Selby M, Brem H, Drake CG, Pardoll DM, Lim M.

J Immunother Cancer. 2016 May 17;4:28. doi: 10.1186/s40425-016-0132-2. Erratum in: J Immunother Cancer. 2016 Nov 4;4:74.

PMID: 27190629

 

Characterization of monoacylglycerol acyltransferase 2 inhibitors by a novel probe in binding assays.

Ma Z, Chao HJ, Turdi H, Hangeland JJ, Friends T, Kopcho LM, Lawrence RM, Cheng D.

Anal Biochem. 2016 May 15;501:48-55. doi: 10.1016/j.ab.2016.02.012.

PMID: 26925857

 

Development of a RapidFire mass spectrometry assay and a fluorescence assay for the discovery of kynurenine aminotransferase II inhibitors to treat central nervous system disorders.

Lu H, Kopcho L, Ghosh K, Witmer M, Parker M, Gupta S, Paul M, Krishnamurthy P, Laksmaiah B, Xie D, Tredup J, Zhang L, Abell LM.

Anal Biochem. 2016 May 15;501:56-65. doi: 10.1016/j.ab.2016.02.003.

PMID: 26874021

 

Orally bioavailable pyridine and pyrimidine-based Factor XIa inhibitors: Discovery of the methyl N-phenyl carbamate P2 prime group.

Corte JR, Fang T, Pinto DJ, Orwat MJ, Rendina AR, Luettgen JM, Rossi KA, Wei A, Ramamurthy V, Myers JE Jr, Sheriff S, Narayanan R, Harper TW, Zheng JJ, Li YX, Seiffert DA, Wexler RR, Quan ML.

Bioorg Med Chem. 2016 May 15;24(10):2257-72. doi: 10.1016/j.bmc.2016.03.062.

PMID: 27073051

 

Identification and synthesis of potent and selective pyridyl-isoxazole based agonists of sphingosine-1-phosphate 1 (S1P1).

Guo J, Watterson SH, Spergel SH, Kempson J, Langevine CM, Shen DR, Yarde M, Cvijic ME, Banas D, Liu R, Suchard SJ, Gillooly K, Taylor T, Rex-Rabe S, Shuster DJ, McIntyre KW, Cornelius G, D'Arienzo C, Marino A, Balimane P, Salter-Cid L, McKinnon M, Barrish JC, Carter PH, Pitts WJ, Xie J, Dyckman AJ.

Bioorg Med Chem Lett. 2016 May 15;26(10):2470-4. doi: 10.1016/j.bmcl.2016.03.105.

PMID: 27055941

 

mTOR Mediates IL-23 Induction of Neutrophil IL-17 and IL-22 Production.

Chen F, Cao A, Yao S, Evans-Marin HL, Liu H, Wu W, Carlsen ED, Dann SM, Soong L, Sun J, Zhao Q, Cong Y.

J Immunol. 2016 May 15;196(10):4390-9. doi: 10.4049/jimmunol.1501541.

PMID: 27067005

 

Biochemical and biophysical characterization of cell-free synthesized Rift Valley fever virus nucleoprotein capsids enables in vitro screening to identify novel antivirals.

Broce S, Hensley L, Sato T, Lehrer-Graiwer J, Essrich C, Edwards KJ, Pajda J, Davis CJ, Bhadresh R, Hurt CR, Freeman B, Lingappa VR, Kelleher CA, Karpuj MV.

Biol Direct. 2016 May 14;11:25. doi: 10.1186/s13062-016-0126-5.

PMID: 27179769

 

A general alkyl-alkyl cross-coupling enabled by redox-active esters and alkylzinc reagents.

Qin T, Cornella J, Li C, Malins LR, Edwards JT, Kawamura S, Maxwell BD, Eastgate MD, Baran PS.

Science. 2016 May 13;352(6287):801-5. doi: 10.1126/science.aaf6123.

PMID: 27103669

 

Use of Chronic Medications Among Patients with Non-Valvular Atrial Fibrillation.

Kocis PT, Liu G, Makenbaeva D, Trocio J, Velott D, Trainer JB, Abdulsattar Y, Molina MI, Leslie DL.

Drugs Real World Outcomes. 2016 May 10;3(2):165-173.

PMID: 27398295

 

Scalable and sustainable electrochemical allylic C-H oxidation.

Horn EJ, Rosen BR, Chen Y, Tang J, Chen K, Eastgate MD, Baran PS.

Nature. 2016 May 5;533(7601):77-81. doi: 10.1038/nature17431.

PMID: 27096371

 

Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study.

D'Agostino MA, Boers M, Wakefield RJ, Berner Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Gaillez C, Le Bars M.

RMD Open. 2016 May 5;2(1):e000237. doi: 10.1136/rmdopen-2015-000237.

PMID: 27175297

 

Erratum to: Incidence of malignancy in adult patients with rheumatoid arthritis: a meta-analysis.

Simon TA, Thompson A, Gandhi KK, Hochberg MC, Suissa S.

Arthritis Res Ther. 2016 May 4;18(1):100. No abstract available.

PMID: 27146822

 

Crystal structures of apo and inhibitor-bound TGFβR2 kinase domain: insights into TGFβR isoform selectivity.

Tebben AJ, Ruzanov M, Gao M, Xie D, Kiefer SE, Yan C, Newitt JA, Zhang L, Kim K, Lu H, Kopcho LM, Sheriff S.

Acta Crystallogr D Struct Biol. 2016 May;72(Pt 5):658-74. doi: 10.1107/S2059798316003624.

PMID: 27139629

 

Impact of Disease Duration on the Effects of Pramlintide in Type 1 Diabetes: A Post Hoc Analysis of Three Clinical Trials.

Herrmann K, Brunell SC, Li Y, Zhou M, Maggs DG.

Adv Ther. 2016 May;33(5):848-61. doi: 10.1007/s12325-016-0326-5.

PMID: 27071768

 

History of bleeding and outcomes with apixaban versus warfarin in patients with atrial fibrillation in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.

De Caterina R, Andersson U, Alexander JH, Al-Khatib SM, Bahit MC, Goto S, Hanna M, Held C, Hohnloser S, Hylek EM, Lanas F, Lopes RD, López-Sendón J, Renda G, Horowitz J, Granger CB, Wallentin L; ARISTOTLE Investigators..

Am Heart J. 2016 May;175:175-83. doi: 10.1016/j.ahj.2016.01.005.

PMID: 27179738

 

LC-quadrupole/Orbitrap high-resolution mass spectrometry enables stable isotope-resolved simultaneous quantification and ¹³C-isotopic labeling of acyl-coenzyme A thioesters.

Frey AJ, Feldman DR, Trefely S, Worth AJ, Basu SS, Snyder NW.

Anal Bioanal Chem. 2016 May;408(13):3651-8. doi: 10.1007/s00216-016-9448-5.

PMID: 26968563

 

Traditional Cardiovascular Disease Risk Factor Management in Rheumatoid Arthritis Compared to Matched Nonrheumatoid Arthritis in a US Managed Care Setting.

An J, Cheetham TC, Reynolds K, Alemao E, Kawabata H, Liao KP, Solomon DH.

Arthritis Care Res (Hoboken). 2016 May;68(5):629-37. doi: 10.1002/acr.22740.

PMID: 26414069

 

Synthesis and evaluation of carbamate and aryl ether substituted pyrazinones as corticotropin releasing factor-1 (CRF₁) receptor antagonists.

Ahuja VT, Hartz RA, Molski TF, Mattson GK, Lentz KA, Grace JE Jr, Lodge NJ, Bronson JJ, Macor JE.

Bioorg Med Chem Lett. 2016 May 1;26(9):2184-7. doi: 10.1016/j.bmcl.2016.03.067.

PMID: 27020524

 

Lymphocytosis after treatment with dasatinib in chronic myeloid leukemia: Effects on response and toxicity.

Schiffer CA, Cortes JE, Hochhaus A, Saglio G, le Coutre P, Porkka K, Mustjoki S, Mohamed H, Shah NP.

Cancer. 2016 May 1;122(9):1398-407. doi: 10.1002/cncr.29933.

PMID: 26998677

 

Efficacy and prognostic factors of treatment retention with intravenous abatacept for rheumatoid arthritis: 24-month results from an international, prospective, real-world study.

Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Peichl P, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M.

Clin Exp Rheumatol. 2016 May-Jun;34(3):489-99.

PMID: 26966919

 

Network meta-analysis of treatments for type 2 diabetes mellitus following failure with metformin plus sulfonylurea.

Lozano-Ortega G, Goring S, Bennett HA, Bergenheim K, Sternhufvud C, Mukherjee J.

Curr Med Res Opin. 2016 May;32(5):807-16. doi: 10.1185/03007995.2015.1135110.

PMID: 26700585

 

Cardiovascular Risk Factor Targets and Cardiovascular Disease Event Risk in Diabetes: A Pooling Project of the Atherosclerosis Risk in Communities Study, Multi-Ethnic Study of Atherosclerosis, and Jackson Heart Study.

Wong ND, Zhao Y, Patel R, Patao C, Malik S, Bertoni AG, Correa A, Folsom AR, Kachroo S, Mukherjee J, Taylor H, Selvin E.

Diabetes Care. 2016 May;39(5):668-76. doi: 10.2337/dc15-2439.

PMID: 27208374

 

Characterization of antibody-drug conjugates by mass spectrometry: advances and future trends.

Huang RY, Chen G.

Drug Discov Today. 2016 May;21(5):850-5. doi: 10.1016/j.drudis.2016.04.004. Review.

PMID: 27080148

 

Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper.

Kraynov E, Kamath AV, Walles M, Tarcsa E, Deslandes A, Iyer RA, Datta-Mannan A, Sriraman P, Bairlein M, Yang JJ, Barfield M, Xiao G, Escandon E, Wang W, Rock DA, Chemuturi NV, Moore DJ.

Drug Metab Dispos. 2016 May;44(5):617-23. doi: 10.1124/dmd.115.068049. Review.

PMID: 26669328

 

Use of acute and chronic ecotoxicity data in environmental risk assessment of pharmaceuticals.

Vestel J, Caldwell DJ, Constantine L, D'Aco VJ, Davidson T, Dolan DG, Millard SP, Murray-Smith R, Parke NJ, Ryan JJ, Straub JO, Wilson P.

Environ Toxicol Chem. 2016 May;35(5):1201-12. doi: 10.1002/etc.3260.

PMID: 26403382

 

Cost-effectiveness analysis of apixaban compared to low-molecularweight heparins and vitamin k antagonists for treatment and secondary prevention of venous thromboembolism.

Elías I, Oyagüez I, Alvarez-Sala LA, García-Bragado F, Navarro A, González P, De Andrés-Nogales F, Soto J.

Farm Hosp. 2016 May 1;40(3):187-208. doi: 10.7399/fh.2016.40.3.10461.

PMID: 27145388

 

Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).

Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, Pol S, Stuart K, Tse E, McPhee F, Bhore R, Jimenez-Exposito MJ, Thompson AJ.

Hepatology. 2016 May;63(5):1430-41. doi: 10.1002/hep.28473.

PMID: 26822022

 

Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.

Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, McPhee F, Hughes EA, Noviello S, Swenson ES.

Hepatology. 2016 May;63(5):1493-505. doi: 10.1002/hep.28446.

PMID: 26754432

 

Exploitation of the Ornithine Effect Enhances Characterization of Stapled and Cyclic Peptides.

Crittenden CM, Parker WR, Jenner ZB, Bruns KA, Akin LD, McGee WM, Ciccimaro E, Brodbelt JS.

J Am Soc Mass Spectrom. 2016 May;27(5):856-63. doi: 10.1007/s13361-016-1355-7.

PMID: 26864791

 

Response to Letter to the Editor From Drs. Stöllberger and Finsterer: Original Publication: "Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban".

Frost C, Chang M, Yu Z, Shenker A, Wang J, Pursley J, Byon W, Boyd RA, LaCreta F.

J Clin Pharmacol. 2016 May;56(5):648-9. doi: 10.1002/jcph.687. No abstract available.

PMID: 27088780

 

Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban.

Chang M, Yu Z, Shenker A, Wang J, Pursley J, Byon W, Boyd RA, LaCreta F, Frost CE.

J Clin Pharmacol. 2016 May;56(5):637-45. doi: 10.1002/jcph.633.

PMID: 26358690

 

Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.

Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D, Song Y, Pursley J, Boyd RA, Frost C.

J Clin Pharmacol. 2016 May;56(5):628-36. doi: 10.1002/jcph.628.

PMID: 26331581

 

Daclatasvir + asunaprevir versus sofosbuvir/ledipasvir for hepatitis C genotype 1 in Japanese patients: an indirect comparison.

Swallow E, Kelley C, Signorovitch J, Wygant G, McPhee F.

J Comp Eff Res. 2016 May;5(3):273-9. doi: 10.2217/cer.15.69.

PMID: 26793987

 

Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B).

Chan HL, Ahn SH, Chang TT, Peng CY, Wong D, Coffin CS, Lim SG, Chen PJ, Janssen HL, Marcellin P, Serfaty L, Zeuzem S, Cohen D, Critelli L, Xu D, Wind-Rotolo M, Cooney E; LIRA-B Study Team..

J Hepatol. 2016 May;64(5):1011-9. doi: 10.1016/j.jhep.2015.12.018.

PMID: 26739688

 

Association Between Weight Change, Clinical Outcomes, and Health Care Costs in Patients with Type 2 Diabetes.

Mukherjee J, Sternhufvud C, Smith N, Bell K, Stott-Miller M, McMorrow D, Johnston S.

J Manag Care Spec Pharm. 2016 May;22(5):449-66. doi: 10.18553/jmcp.2016.22.5.449.

PMID: 27123909

 

The function and performance of aqueous aerosol devices for inhalation therapy.

Carvalho TC, McConville JT.

J Pharm Pharmacol. 2016 May;68(5):556-78. doi: 10.1111/jphp.12541. Review.

PMID: 27061412

 

Coproporphyrins I and III as Functional Markers of OATP1B Activity: In Vitro and In Vivo Evaluation in Preclinical Species.

Shen H, Dai J, Liu T, Cheng Y, Chen W, Freeden C, Zhang Y, Humphreys WG, Marathe P, Lai Y.

J Pharmacol Exp Ther. 2016 May;357(2):382-93. doi: 10.1124/jpet.116.232066.

PMID: 26907622

 

Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration.

Mattila J, Clark M, Liu S, Pieracci J, Gervais TR, Wilson E, Galperina O, Li X, Roush D, Zoeller K, Brough H, Simpson-Platre C.

PDA J Pharm Sci Technol. 2016 May-Jun;70(3):293-9. doi: 10.5731/pdajpst.2016.006478.

PMID: 27020645

 

A Roadmap for the Implementation of Continued Process Verification.

Boyer M, Gampfer J, Zamamiri A, Payne R.

PDA J Pharm Sci Technol. 2016 May-Jun;70(3):282-92. doi: 10.5731/pdajpst.2015.006395.

PMID: 27020644

 

Investigation of Air-Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents.

Shi T, Ding W, Kessler DW, De Mas N, Weaver DG, Pathirana C, Martin RD, Mackin NA, Casati M, Miller SA, Pla IA.

PDA J Pharm Sci Technol. 2016 May-Jun;70(3):272-81. doi: 10.5731/pdajpst.2015.005736.

PMID: 26797969

 

Characterization of Supersaturated Danazol Solutions - Impact of Polymers on Solution Properties and Phase Transitions.

Jackson MJ, Kestur US, Hussain MA, Taylor LS.

Pharm Res. 2016 May;33(5):1276-88. doi: 10.1007/s11095-016-1871-y.

PMID: 26892947

 

Osmotic diuresis with SGLT2 inhibition: analysis of events related to volume reduction in dapagliflozin clinical trials.

Johnsson K, Johnsson E, Mansfield TA, Yavin Y, Ptaszynska A, Parikh SJ.

Postgrad Med. 2016 May;128(4):346-55. doi: 10.1080/00325481.2016.1153941.

PMID: 26878357

 

Cost analysis of biologic drugs in rheumatoid arthritis first line treatment after methotrexate failure according to patients' body weight.

Román Ivorra JA, Ivorra J, Monte-Boquet E, Canal C, Oyagüez I, Gómez-Barrera M.

Reumatol Clin. 2016 May-Jun;12(3):123-9. doi: 10.1016/j.reuma.2015.07.008. English, Spanish.

PMID: 26362842

 

Cardiovascular risk factor management in patients with RA compared to matched non-RA patients.

Alemao E, Cawston H, Bourhis F, Al M, Rutten-van Mölken MP, Liao KP, Solomon DH.

Rheumatology (Oxford). 2016 May;55(5):809-16. doi: 10.1093/rheumatology/kev427.

PMID: 26705329

  

Evolution of the microstructure during the process of consolidation and bonding in soft granular solids.

Yohannes B, Gonzalez M, Abebe A, Sprockel O, Nikfar F, Kiang S, Cuitiño AM.

Int J Pharm. 2016 Apr 30;503(1-2):68-77. doi: 10.1016/j.ijpharm.2016.02.032.

PMID: 26902721

 

Atropisomer Control in Macrocyclic Factor VIIa Inhibitors.

Glunz PW, Mueller L, Cheney DL, Ladziata V, Zou Y, Wurtz NR, Wei A, Wong PC, Wexler RR, Priestley ES.

J Med Chem. 2016 Apr 28;59(8):4007-18. doi: 10.1021/acs.jmedchem.6b00244.

PMID: 27015008

 

The Pathogenic A116V Mutation Enhances Ion-Selective Channel Formation by Prion Protein in Membranes.

Sabareesan AT, Singh J, Roy S, Udgaonkar JB, Mathew MK.

Biophys J. 2016 Apr 26;110(8):1766-76. doi: 10.1016/j.bpj.2016.03.017.

PMID: 27119637

 

Discovery of BMS-955176, a Second Generation HIV-1 Maturation Inhibitor with Broad Spectrum Antiviral Activity.

Regueiro-Ren A, Liu Z, Chen Y, Sin N, Sit SY, Swidorski JJ, Chen J, Venables BL, Zhu J, Nowicka-Sans B, Protack T, Lin Z, Terry B, Samanta H, Zhang S, Li Z, Beno BR, Huang XS, Rahematpura S, Parker DD, Haskell R, Jenkins S, Santone KS, Cockett MI, Krystal M, Meanwell NA, Hanumegowda U, Dicker IB.

ACS Med Chem Lett. 2016 Apr 22;7(6):568-72. doi: 10.1021/acsmedchemlett.6b00010.

PMID: 27326328

 

Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529.

Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ.

Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15.

PMID: 26902761

 

PD-1 marks dysfunctional regulatory T cells in malignant gliomas.

Lowther DE, Goods BA, Lucca LE, Lerner BA, Raddassi K, van Dijk D, Hernandez AL, Duan X, Gunel M, Coric V, Krishnaswamy S, Love JC, Hafler DA.

JCI Insight. 2016 Apr 21;1(5). pii: e85935.

PMID: 27182555

 

Attenuated total reflection-Fourier transform infrared spectroscopic imaging of pharmaceuticals in microfluidic devices.

Ewing AV, Clarke GS, Kazarian SG.

Biomicrofluidics. 2016 Apr 20;10(2):024125. doi: 10.1063/1.4946867.

PMID: 27158293

 

Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration.

Schiff M, Weinblatt ME, Valente R, Citera G, Maldonado M, Massarotti E, Yazici Y, Fleischmann R.

RMD Open. 2016 Apr 19;2(1):e000210. doi: 10.1136/rmdopen-2015-000210.

PMID: 27110385

 

Toxicology Strategies for Drug Discovery - Present and Future: Introduction.

Humphreys WG, Will Y, Guengerich FP.

Chem Res Toxicol. 2016 Apr 18;29(4):437. doi: 10.1021/acs.chemrestox.6b00049. No abstract available.

PMID: 27087588

 

Improving Drug Design: An Update on Recent Applications of Efficiency Metrics, Strategies for Replacing Problematic Elements, and Compounds in Nontraditional Drug Space.

Meanwell NA.

Chem Res Toxicol. 2016 Apr 18;29(4):564-616. doi: 10.1021/acs.chemrestox.6b00043. Review.

PMID: 26974882

 

Involvement of Drug Transporters in Organ Toxicity: The Fundamental Basis of Drug Discovery and Development.

Cheng Y, El-Kattan A, Zhang Y, Ray AS, Lai Y.

Chem Res Toxicol. 2016 Apr 18;29(4):545-63. doi: 10.1021/acs.chemrestox.5b00511. Review.

PMID: 26889774

 

In Vitro Developmental Toxicology Screens: A Report on the Progress of the Methodology and Future Applications.

Zhang C, Ball J, Panzica-Kelly J, Augustine-Rauch K.

Chem Res Toxicol. 2016 Apr 18;29(4):534-44. doi: 10.1021/acs.chemrestox.5b00458. Review.

PMID: 26766213

 

Quantitation of a PEGylated protein in monkey serum by UHPLC-HRMS using a surrogate disulfide-containing peptide: A new approach to bioanalysis and in vivo stability evaluation of disulfide-rich protein therapeutics.

Zheng N, Zeng J, Manney A, Williams L, Aubry AF, Voronin K, Buzescu A, Zhang YJ, Allentoff A, Xu C, Shen H, Warner W, Arnold ME.

Anal Chim Acta. 2016 Apr 15;916:42-51. doi: 10.1016/j.aca.2016.02.017.

PMID: 27016437

 

C-3 benzoic acid derivatives of C-3 deoxybetulinic acid and deoxybetulin as HIV-1 maturation inhibitors.

Liu Z, Swidorski JJ, Nowicka-Sans B, Terry B, Protack T, Lin Z, Samanta H, Zhang S, Li Z, Parker DD, Rahematpura S, Jenkins S, Beno BR, Krystal M, Meanwell NA, Dicker IB, Regueiro-Ren A.

Bioorg Med Chem. 2016 Apr 15;24(8):1757-70. doi: 10.1016/j.bmc.2016.03.001.

PMID: 26968652

 

Inhibitors of HIV-1 maturation: Development of structure-activity relationship for C-28 amides based on C-3 benzoic acid-modified triterpenoids.

Swidorski JJ, Liu Z, Sit SY, Chen J, Chen Y, Sin N, Venables BL, Parker DD, Nowicka-Sans B, Terry BJ, Protack T, Rahematpura S, Hanumegowda U, Jenkins S, Krystal M, Dicker IB, Meanwell NA, Regueiro-Ren A.

Bioorg Med Chem Lett. 2016 Apr 15;26(8):1925-30. doi: 10.1016/j.bmcl.2016.03.019.

PMID: 26988305

 

Brief Report: Switch to Ritonavir-Boosted Atazanavir Plus Raltegravir in Virologically Suppressed Patients With HIV-1 Infection: A Randomized Pilot Study.

van Lunzen J, Pozniak A, Gatell JM, Antinori A, Klauck I, Serrano O, Baakili A, Osiyemi O, Sevinsky H, Girard PM.

J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):538-43. doi: 10.1097/QAI.0000000000000904.

PMID: 26605505

 

Expedient Synthesis of Furo[2,3-d][1,3]thiazinamines and Pyrano[2,3-d][1,3]thiazinamines from Enones and Thiourea.

Wu YJ, Guernon J, Park H, Thompson LA.

J Org Chem. 2016 Apr 15;81(8):3386-90. doi: 10.1021/acs.joc.5b02705.

PMID: 27002691

 

Synergistic Catalysis: Pd(II) Catalyzed Oxidation of 1,4-Dihydroquinones in the Pd(II) Catalyzed 1,4-Oxidation of Cyclic 1,3-Dienes.

Zheng B, Schmidt MA, Eastgate MD.

J Org Chem. 2016 Apr 15;81(8):3112-8. doi: 10.1021/acs.joc.5b02769.

PMID: 26925844

 

The Human Vaccines Project: A roadmap for cancer vaccine development.

Romero P, Banchereau J, Bhardwaj N, Cockett M, Disis ML, Dranoff G, Gilboa E, Hammond SA, Hershberg R, Korman AJ, Kvistborg P, Melief C, Mellman I, Palucka AK, Redchenko I, Robins H, Sallusto F, Schenkelberg T, Schoenberger S, Sosman J, Türeci Ö, Van den Eynde B, Koff W, Coukos G.

Sci Transl Med. 2016 Apr 13;8(334):334ps9. doi: 10.1126/scitranslmed.aaf0685. Review.

PMID: 27075624

 

Understanding CKD among patients with T2DM: prevalence, temporal trends, and treatment patterns-NHANES 2007-2012.

Wu B, Bell K, Stanford A, Kern DM, Tunceli O, Vupputuri S, Kalsekar I, Willey V.

BMJ Open Diabetes Res Care. 2016 Apr 11;4(1):e000154. doi: 10.1136/bmjdrc-2015-000154.

PMID: 27110365

 

Long-term drug costs per life-month gained associated with first-line treatments for unresectable or metastatic melanoma.

Liu JS, Rao S.

Exp Hematol Oncol. 2016 Apr 11;5:9. doi: 10.1186/s40164-016-0039-0.

PMID: 27069772

 

Transthyretin Suppresses Amyloid-β Secretion by Interfering with Processing of the Amyloid-β Protein Precursor.

Li X, Song Y, Sanders CR, Buxbaum JN.

J Alzheimers Dis. 2016 Apr 8;52(4):1263-75. doi: 10.3233/JAD-160033.

PMID: 27079720

 

Outcome of the First wwPDB/CCDC/D3R Ligand Validation Workshop.

Adams PD, Aertgeerts K, Bauer C, Bell JA, Berman HM, Bhat TN, Blaney JM, Bolton E, Bricogne G, Brown D, Burley SK, Case DA, Clark KL, Darden T, Emsley P, Feher VA, Feng Z, Groom CR, Harris SF, Hendle J, Holder T, Joachimiak A, Kleywegt GJ, Krojer T, Marcotrigiano J, Mark AE, Markley JL, Miller M, Minor W, Montelione GT, Murshudov G, Nakagawa A, Nakamura H, Nicholls A, Nicklaus M, Nolte RT, Padyana AK, Peishoff CE, Pieniazek S, Read RJ, Shao C, Sheriff S, Smart O, Soisson S, Spurlino J, Stouch T, Svobodova R, Tempel W, Terwilliger TC, Tronrud D, Velankar S, Ward SC, Warren GL, Westbrook JD, Williams P, Yang H, Young J.

Structure. 2016 Apr 5;24(4):502-8. doi: 10.1016/j.str.2016.02.017.

PMID: 27050687

 

Discovery and Preclinical Evaluation of BMS-711939, an Oxybenzylglycine Based PPARα Selective Agonist.

Shi Y, Li J, Kennedy LJ, Tao S, Hernández AS, Lai Z, Chen S, Wong H, Zhu J, Trehan A, Lim NK, Zhang H, Chen BC, Locke KT, O'Malley KM, Zhang L, Srivastava RA, Miao B, Meyers DS, Monshizadegan H, Search D, Grimm D, Zhang R, Harrity T, Kunselman LK, Cap M, Muckelbauer J, Chang C, Krystek SR, Li YX, Hosagrahara V, Zhang L, Kadiyala P, Xu C, Blanar MA, Zahler R, Mukherjee R, Cheng PT, Tino JA.

ACS Med Chem Lett. 2016 Apr 4;7(6):590-4. doi: 10.1021/acsmedchemlett.6b00033.

PMID: 27326332

 

Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Öhman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF.

Am Heart J. 2016 Apr;174:103-10. doi: 10.1016/j.ahj.2015.12.009.

PMID: 26995376

 

Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa.

Vakkalagadda B, Frost C, Byon W, Boyd RA, Wang J, Zhang D, Yu Z, Dias C, Shenker A, LaCreta F.

Am J Cardiovasc Drugs. 2016 Apr;16(2):119-27. doi: 10.1007/s40256-015-0157-9.

PMID: 26749408

 

CD57(+) CD4 T Cells Underlie Belatacept-Resistant Allograft Rejection.

Espinosa J, Herr F, Tharp G, Bosinger S, Song M, Farris AB 3rd, George R, Cheeseman J, Stempora L, Townsend R, Durrbach A, Kirk AD.

Am J Transplant. 2016 Apr;16(4):1102-12. doi: 10.1111/ajt.13613.

PMID: 26603381

 

Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial.

Sokolove J, Schiff M, Fleischmann R, Weinblatt ME, Connolly SE, Johnsen A, Zhu J, Maldonado MA, Patel S, Robinson WH.

Ann Rheum Dis. 2016 Apr;75(4):709-14. doi: 10.1136/annrheumdis-2015-207942.

PMID: 26359449

 

Techniques for quantitative LC-MS/MS analysis of protein therapeutics: advances in enzyme digestion and immunocapture.

Fung EN, Bryan P, Kozhich A.

Bioanalysis. 2016 Apr;8(8):847-56. doi: 10.4155/bio.16.24. Review.

PMID: 27005854

 

Structure activity relationship studies on chemically non-reactive glycine sulfonamide inhibitors of diacylglycerol lipase.

Chupak LS, Zheng X, Hu S, Huang Y, Ding M, Lewis MA, Westphal RS, Blat Y, McClure A, Gentles RG.

Bioorg Med Chem. 2016 Apr 1;24(7):1455-68. doi: 10.1016/j.bmc.2016.02.006.

PMID: 26917221

 

Clarification technologies for monoclonal antibody manufacturing processes: Current state and future perspectives.

Singh N, Arunkumar A, Chollangi S, Tan ZG, Borys M, Li ZJ.

Biotechnol Bioeng. 2016 Apr;113(4):698-716. doi: 10.1002/bit.25810. Review.

PMID: 26302443

 

De-Risking Immunotherapy: Report of a Consensus Workshop of the Cancer Immunotherapy Consortium of the Cancer Research Institute.

Mellman I, Hubbard-Lucey VM, Tontonoz MJ, Kalos MD, Chen DS, Allison JP, Drake CG, Levitsky H, Lonberg N, van der Burg SH, Fearon DT, Wherry EJ, Lowy I, Vonderheide RH, Hwu P.

Cancer Immunol Res. 2016 Apr;4(4):279-88. doi: 10.1158/2326-6066.CIR-16-0045. Review.

PMID: 27036972

 

Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy.

Eigentler TK, Hassel JC, Berking C, Aberle J, Bachmann O, Grünwald V, Kähler KC, Loquai C, Reinmuth N, Steins M, Zimmer L, Sendl A, Gutzmer R.

Cancer Treat Rev. 2016 Apr;45:7-18. doi: 10.1016/j.ctrv.2016.02.003. Review.

PMID: 26922661

 

The Association Between Bleeding and the Incidence of Warfarin Discontinuation in Patients with Atrial Fibrillation.

Simon TA, Pan X, Kawabata H, Huang HY, Azoulay L.

Cardiovasc Ther. 2016 Apr;34(2):94-9. doi: 10.1111/1755-5922.12174.

PMID: 26763662

 

Mechanistic Modeling of Pitavastatin Disposition in Sandwich-Cultured Human Hepatocytes: A Proteomics-Informed Bottom-Up Approach.

Vildhede A, Mateus A, Khan EK, Lai Y, Karlgren M, Artursson P, Kjellsson MC.

Drug Metab Dispos. 2016 Apr;44(4):505-16. doi: 10.1124/dmd.115.066746.

PMID: 26842596

 

Burden of stroke and other cardiovascular complications in patients with atrial fibrillation hospitalized in France.

Cotté FE, Chaize G, Gaudin AF, Samson A, Vainchtock A, Fauchier L.

Europace. 2016 Apr;18(4):501-7. doi: 10.1093/europace/euv248.

PMID: 26718532

 

Multimodal imaging analysis of an orthotopic head and neck cancer mouse model and application of anti-CD137 tumor immune therapy.

Vahle AK, Hermann S, Schäfers M, Wildner M, Kerem A, Öztürk E, Jure-Kunkel M, Franklin C, Lang S, Brandau S.

Head Neck. 2016 Apr;38(4):542-9. doi: 10.1002/hed.23929.

PMID: 25482887

 

Biomarkers of inflammation and risk of cardiovascular events in anticoagulated patients with atrial fibrillation.

Hijazi Z, Aulin J, Andersson U, Alexander JH, Gersh B, Granger CB, Hanna M, Horowitz J, Hylek EM, Lopes RD, Siegbahn A, Wallentin L; ARISTOTLE Investigators..

Heart. 2016 Apr;102(7):508-17. doi: 10.1136/heartjnl-2015-308887.

PMID: 26839066

 

Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study.

Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hébuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A.

J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224.

PMID: 26721935

 

Synthesis of isotopically labeled daclatasvir for use in human clinical studies.

Easter JA, Burrell RC, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Apr;59(4):164-70. doi: 10.1002/jlcr.3386.

PMID: 26968868

 

Lost Labor Productivity Costs of Prostate Cancer to Patients and Their Spouses: Evidence From US National Survey Data.

Rizzo JA, Zyczynski TM, Chen J, Mallow PJ, Trudel GC, Penrod JR.

J Occup Environ Med. 2016 Apr;58(4):351-8. doi: 10.1097/JOM.0000000000000621.

PMID: 27058474

 

Dehydration and Stabilization of a Reactive Tertiary Hydroxyl Group in Solid Oral Dosage Forms of BMS-779788.

Adams ML, Sharma V, Gokhale M, Huang Y, Stefanski K, Su C, Hussain MA.

J Pharm Sci. 2016 Apr;105(4):1478-88. doi: 10.1016/j.xphs.2015.12.028.

PMID: 26921118

 

193TiP: CheckMate 171: A multicenter phase 2 trial of nivolumab (nivo) in patients (pts) with stage IIIB/IV squamous cell (SQ) NSCLC who have received ≥1 prior systemic treatment.

Felip E, Van Meerbeeck J, Wolf J, Ardizzoni A, Li A, Srinivasan S, Popat S.

J Thorac Oncol. 2016 Apr;11(4 Suppl):S141. doi: 10.1016/S1556-0864(16)30302-1. No abstract available.

PMID: 27198331

 

137O: Nivolumab in patients (pts) with advanced refractory squamous (SQ) non-small cell lung cancer (NSCLC): 2-year follow-up from CheckMate 063 and exploratory cytokine profling analyses.

Lena H, Rizvi NA, Wolf J, Cappuzzo F, Zalcman G, Baas P, Mazieres J, Farsaci B, Blackwood-Chirchir MA, Ramalingam S.

J Thorac Oncol. 2016 Apr;11(4 Suppl):S115-6. doi: 10.1016/S1556-0864(16)30247-7. No abstract available.

PMID: 27198275

 

The P2Y1 receptor antagonist MRS2500 prevents carotid artery thrombosis in cynomolgus monkeys.

Wong PC, Watson C, Crain EJ.

J Thromb Thrombolysis. 2016 Apr;41(3):514-21. doi: 10.1007/s11239-015-1302-7.

PMID: 26660522

 

Investigation of Color in a Fusion Protein Using Advanced Analytical Techniques: Delineating Contributions from Oxidation Products and Process Related Impurities.

Song H, Xu J, Jin M, Huang C, Bongers J, Bai H, Wu W, Ludwig R, Li Z, Tao L, Das TK.

Pharm Res. 2016 Apr;33(4):932-41. doi: 10.1007/s11095-015-1839-3.

PMID: 26658915

 

The qEEG Signature of Selective NMDA NR2B Negative Allosteric Modulators; A Potential Translational Biomarker for Drug Development.

Keavy D, Bristow LJ, Sivarao DV, Batchelder M, King D, Thangathirupathy S, Macor JE, Weed MR.

PLoS One. 2016 Apr 1;11(4):e0152729. doi: 10.1371/journal.pone.0152729.

PMID: 27035340

 

The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey.

Colleton C, Brewster D, Chester A, Clarke DO, Heining P, Olaharski A, Graziano M.

Toxicol Pathol. 2016 Apr;44(3):458-66. doi: 10.1177/0192623315617562.

PMID: 27006130

 

Risk of Cardiovascular Events Among Patients Initiating Efavirenz-Containing Versus Efavirenz-Free Antiretroviral Regimens.

Rosenblatt L, Farr AM, Johnston SS, Nkhoma ET.

Open Forum Infect Dis. 2016 Mar 30;3(2):ofw061. doi: 10.1093/ofid/ofw061.

PMID: 27186585

 

Ensemble Modeling and Intracellular Aggregation of an Engineered Immunoglobulin-Like Domain.

Trainor K, Gingras Z, Shillingford C, Malakian H, Gosselin M, Lipovšek D, Meiering EM.

J Mol Biol. 2016 Mar 27;428(6):1365-74. doi: 10.1016/j.jmb.2016.02.016.

PMID: 26903090

 

Quantitation of repaglinide and metabolites in mouse whole-body thin tissue sections using droplet-based liquid microjunction surface sampling-high-performance liquid chromatography-electrospray ionization tandem mass spectrometry.

Chen W, Wang L, Van Berkel GJ, Kertesz V, Gan J.

J Chromatogr A. 2016 Mar 25;1439:137-43. doi: 10.1016/j.chroma.2015.10.093.

PMID: 26589943

 

Potent and Selective Agonists of Sphingosine 1-Phosphate 1 (S1P1): Discovery and SAR of a Novel Isoxazole Based Series.

Watterson SH, Guo J, Spergel SH, Langevine CM, Moquin RV, Shen DR, Yarde M, Cvijic ME, Banas D, Liu R, Suchard SJ, Gillooly K, Taylor T, Rex-Rabe S, Shuster DJ, McIntyre KW, Cornelius G, D'Arienzo C, Marino A, Balimane P, Warrack B, Salter-Cid L, McKinnon M, Barrish JC, Carter PH, Pitts WJ, Xie J, Dyckman AJ.

J Med Chem. 2016 Mar 24;59(6):2820-40. doi: 10.1021/acs.jmedchem.6b00089.

PMID: 26924461

 

Building homogeneous time-resolved fluorescence resonance energy transfer assays for characterization of bivalent inhibitors of an inhibitor of apoptosis protein target.

Chaudhry C, Davis J, Zhang Y, Posy S, Lei M, Shen H, Yan C, Devaux B, Zhang L, Blat Y, Metzler W, Borzilleri RM, Talbott RL.

Anal Biochem. 2016 Mar 15;497:8-17. doi: 10.1016/j.ab.2015.11.026.

PMID: 26743718

 

Synthesis of pyrimido[4,5-c]azepine- and pyrimido[4,5-c]oxepine-based γ-secretase modulators.

Wu YJ, Zhang Y, Toyn JH, Macor JE, Thompson LA.

Bioorg Med Chem Lett. 2016 Mar 15;26(6):1554-7. doi: 10.1016/j.bmcl.2016.02.016.

PMID: 26898338

 

Phosphocholine conjugation: an unexpected in vivo conjugation pathway associated with hepatitis c ns5b inhibitors featuring a bicyclo[1.1.1]pentane.

Zhuo X, Cantone JL, Wang Y, Leet JE, Drexler DM, Yeung KS, Huang XS, Eastman KJ, Parcella KE, Mosure KW, Soars MG, Kadow JF, Johnson BM.

Drug Metab Dispos. 2016 Mar 9. pii: dmd.115.069062. [Epub ahead of print]

PMID: 26961241

 

Evaluation of the Microcentrifuge Dissolution Method as a Tool for Spray-Dried Dispersion.

Wu B, Li J, Wang Y.

AAPS J. 2016 Mar;18(2):346-53. doi: 10.1208/s12248-016-9872-7.

PMID: 26831250

 

Pre-existing Antibody: Biotherapeutic Modality-Based Review.

Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L.

AAPS J. 2016 Mar;18(2):311-20. doi: 10.1208/s12248-016-9878-1. Review.

PMID: 26821802

 

Assessment of low-dose i.v. ketamine infusions for adjunctive analgesia.

Kator S, Correll DJ, Ou JY, Levinson R, Noronha GN, Adams CD.

Am J Health Syst Pharm. 2016 Mar 1;73(5 Suppl 1):S22-9. doi: 10.2146/ajhp150367.

PMID: 26896522

 

Pharmacologic Prophylaxis for Venous Thromboembolism Among Patients With Total Joint Replacement: An Electronic Medical Records Study.

Rosenman M, Liu X, Phatak H, Qi R, Teal E, Nisi D, Liu LZ, Parr JA.

Am J Ther. 2016 Mar-Apr;23(2):e336-44. doi: 10.1097/01.mjt.0000433946.78535.84.

PMID: 26736015

 

Pharmacological Prophylaxis for Venous Thromboembolism Among Hospitalized Patients With Acute Medical Illness: An Electronic Medical Records Study.

Rosenman M, Liu X, Phatak H, Qi R, Teal E, Nisi D, Liu LZ, Ramacciotti E.

Am J Ther. 2016 Mar-Apr;23(2):e328-35. doi: 10.1097/01.mjt.0000433945.70911.7c.

PMID: 26720163

 

Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data.

Alemao E, Joo S, Kawabata H, Al MJ, Allison PD, Rutten-van Mölken MP, Frits ML, Iannaccone CK, Shadick NA, Weinblatt ME.

Arthritis Care Res (Hoboken). 2016 Mar;68(3):308-17. doi: 10.1002/acr.22678.

PMID: 26238974

 

Abatacept Inhibition of T Cell Priming in Mice by Induction of a Unique Transcriptional Profile That Reduces Their Ability to Activate Antigen-Presenting Cells.

Patakas A, Ji RR, Weir W, Connolly SE, Benson RA, Nadler SG, Brewer JM, McInnes IB, Garside P.

Arthritis Rheumatol. 2016 Mar;68(3):627-38. doi: 10.1002/art.39470.

PMID: 26473409

 

Validation of an integrated series of ligand-binding assays for the quantitative determination of antibody-drug conjugates in biological matrices.

Myler H, Rangan VS, Kozhich A, Hoffpauir B, Dail D, Cummings J, Saewert M, Manney A, Liu A, Rao C, Wang J, Pillutla R, DeSilva B.

Bioanalysis. 2016 Mar;8(6):519-31. doi: 10.4155/bio.16.13.

PMID: 26915587

 

Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines.

Frye C, Deshpande R, Estes S, Francissen K, Joly J, Lubiniecki A, Munro T, Russell R, Wang T, Anderson K.

Biologicals. 2016 Mar;44(2):117-22. doi: 10.1016/j.biologicals.2016.01.001. Review.

PMID: 26852257

 

Design and optimization of tricyclic gamma-secretase modulators.

Shi J, Zuev D, Xu L, Lentz KA, Grace JE, Toyn JH, Olson RE, Macor JE, Thompson LA.

Bioorg Med Chem Lett. 2016 Mar 1;26(5):1498-502. doi: 10.1016/j.bmcl.2015.06.020.

PMID: 26848108

 

Pharmacokinetic characterization of BMS-936561, an anti-CD70 antibody-drug conjugate, in preclinical animal species and prediction of its pharmacokinetics in humans.

Wang H, Rangan VS, Sung MC, Passmore D, Kempe T, Wang X, Thevanayagam L, Pan C, Rao C, Srinivasan M, Zhang Q, Gangwar S, Deshpande S, Cardarelli P, Marathe P, Yang Z.

Biopharm Drug Dispos. 2016 Mar;37(2):93-106. doi: 10.1002/bdd.1953.

PMID: 25869904

 

Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab.

Agrawal S, Waxman I, Lambert A, Roy A, Darbenzio R.

Cancer Chemother Pharmacol. 2016 Mar;77(3):635-41. doi: 10.1007/s00280-016-2980-3.

PMID: 26861469

 

Pharmacokinetics and Safety of Elotuzumab Combined With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma and Various Levels of Renal Impairment: Results of a Phase Ib Study.

Berdeja J, Jagannath S, Zonder J, Badros A, Kaufman JL, Manges R, Gupta M, Tendolkar A, Lynch M, Bleickardt E, Paliwal P, Vij R.

Clin Lymphoma Myeloma Leuk. 2016 Mar;16(3):129-38. doi: 10.1016/j.clml.2015.12.007.

PMID :26795075

 

Cost-effectiveness of Apixaban Versus Other Oral Anticoagulants for the Initial Treatment of Venous Thromboembolism and Prevention of Recurrence.

Lanitis T, Leipold R, Hamilton M, Rublee D, Quon P, Browne C, Cohen AT.

Clin Ther. 2016 Mar;38(3):478-93.e1-16. doi: 10.1016/j.clinthera.2016.01.020.

PMID: 26922297

 

Saxagliptin improves glycaemic control and C-peptide secretion in latent autoimmune diabetes in adults (LADA).

Buzzetti R, Pozzilli P, Frederich R, Iqbal N, Hirshberg B.

Diabetes Metab Res Rev. 2016 Mar;32(3):289-96. doi: 10.1002/dmrr.2717.

PMID: 26385269

 

Comparison of the pharmacokinetics and pharmacodynamics of dapagliflozin in patients with type 1 versus type 2 diabetes mellitus.

Tang W, Leil TA, Johnsson E, Boulton DW, LaCreta F.

Diabetes Obes Metab. 2016 Mar;18(3):236-40. doi: 10.1111/dom.12594.

PMID: 26510924

 

Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis.

Yavin Y, Mansfield TA, Ptaszynska A, Johnsson K, Parikh S, Johnsson E.

Diabetes Ther. 2016 Mar;7(1):125-37. doi: 10.1007/s13300-015-0150-y.

PMID: 26758563

 

Diclofenac and Its Acyl Glucuronide: Determination of In Vivo Exposure in Human Subjects and Characterization as Human Drug Transporter Substrates In Vitro.

Zhang Y, Han YH, Putluru SP, Matta MK, Kole P, Mandlekar S, Furlong MT, Liu T, Iyer RA, Marathe P, Yang Z, Lai Y, Rodrigues AD.

Drug Metab Dispos. 2016 Mar;44(3):320-8. doi: 10.1124/dmd.115.066944.

PMID: 26714763

 

Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.

Jackson N, Atar D, Borentain M, Breithardt G, van Eickels M, Endres M, Fraass U, Friede T, Hannachi H, Janmohamed S, Kreuzer J, Landray M, Lautsch D, Le Floch C, Mol P, Naci H, Samani NJ, Svensson A, Thorstensen C, Tijssen J, Vandzhura V, Zalewski A, Kirchhof P.

Eur Heart J. 2016 Mar 1;37(9):747-54. doi: 10.1093/eurheartj/ehv213. Review.

PMID: 26077039

 

Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunotherapy.

Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, Azpilikueta A, Etxeberria I, Bolaños E, Lang V, Rodriguez M, Aznar MA, Jure-Kunkel M, Melero I.

Eur J Immunol. 2016 Mar;46(3):513-22. doi: 10.1002/eji.201445388. Review.

PMID: 26773716

 

Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules.

Macchi E, Zema L, Pandey P, Gazzaniga A, Felton LA.

Eur J Pharm Biopharm. 2016 Mar;100:47-57. doi: 10.1016/j.ejpb.2015.11.021.

PMID: 26686650

 

Viral hepatitis screening guideline before biological drug use in rheumatic patients.

Karadağ Ö, Kaşifoğlu T, Özer B, Kaymakoğlu S, Kuş Y, İnanç M, Keser G, Kiraz S.

Eur J Rheumatol. 2016 Mar;3(1):25-28. Review.

PMID 27708965

 

Estimating the cost-effectiveness of daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b.

McEwan P, Ward T, Webster S, Yuan Y, Kalsekar A, Kamae I, Kobayashi M, Tang A, Kumada H.

Hepatol Res. 2016 Mar;46(5):423-33. doi: 10.1111/hepr.12570.

PMID: 26440999

 

Comparison of real-world acute care interventions (ACI) in patients (pts) with advanced non-small cell lung cancer (adv NSCLC) treated with chemotherapy versus targeted therapies.

Korytowsky B, Bhor M, Tuell K, Feinberg BA.

J Clin Oncol. 2016 Mar;34(7_suppl):37. doi: 10.1200/jco.2016.34.7_suppl.37.

PMID: 28152720

 

Daclatasvir + sofosbuvir versus standard of care for hepatitis C genotype 3: a matching-adjusted indirect comparison.

Swallow E, Song J, Yuan Y, Kalsekar A, Kelley C, Mu F, Kim S, Noviello S, Signorovitch J.

J Comp Eff Res. 2016 Mar;5(2):129-39. doi: 10.2217/cer.15.49.

PMID: 26390233

 

Relating Protein-Protein Interactions and Aggregation Rates From Low to High Concentrations.

Ghosh R, Calero-Rubio C, Saluja A, Roberts CJ.

J Pharm Sci. 2016 Mar;105(3):1086-96. doi: 10.1016/j.xphs.2016.01.004.

PMID: 26928400

 

An Approach to Mitigate Particle Formation on the Dilution of a Monoclonal Antibody Drug Product in an IV Administration Fluid.

Zheng S, Adams M, Mantri RV.

J Pharm Sci. 2016 Mar;105(3):1349-50. doi: 10.1016/j.xphs.2015.12.013.

PMID: 26886343

 

Application of Cassette Ultracentrifugation Using Non-labeled Compounds and Liquid Chromatography-Tandem Mass Spectrometry Analysis for High-Throughput Protein Binding Determination.

Kieltyka K, McAuliffe B, Cianci C, Drexler DM, Shou W, Zhang J.

J Pharm Sci. 2016 Mar;105(3):1036-42. doi: 10.1016/S0022-3549(15)00177-X.

PMID: 26886323

 

Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomised, double-blind, placebo-controlled, phase 3 study.

Weber MA, Mansfield TA, Cain VA, Iqbal N, Parikh S, Ptaszynska A.

Lancet Diabetes Endocrinol. 2016 Mar;4(3):211-20. doi: 10.1016/S2213-8587(15)00417-9. Erratum in: Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3.

PMID: 26620248

 

Biochemical and behavioral effects of PDE10A inhibitors: Relationship to target site occupancy.

Li YW, Seager MA, Wojcik T, Heman K, Molski TF, Fernandes A, Langdon S, Pendri A, Gerritz S, Tian Y, Hong Y, Gallagher L, Merritt JR, Zhang C, Westphal R, Zaczek R, Macor JE, Bronson JJ, Lodge NJ.

Neuropharmacology. 2016 Mar;102:121-35. doi: 10.1016/j.neuropharm.2015.10.037.

PMID: 26522433

 

HESI/FDA workshop on immunomodulators and cancer risk assessment: Building blocks for a weight-of-evidence approach.

Lebrec H, Brennan FR, Haggerty H, Herzyk D, Kamperschroer C, Maier CC, Ponce R, Preston BD, Weinstock D, Mellon RD.

Regul Toxicol Pharmacol. 2016 Mar;75:72-80. doi: 10.1016/j.yrtph.2015.12.018.

PMID: 26743742

 

Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring.

Stewart J, Breslin WJ, Beyer BK, Chadwick K, De Schaepdrijver L, Desai M, Enright B, Foster W, Hui JY, Moffat GJ, Tornesi B, Van Malderen K, Wiesner L, Chen CL.

Ther Innov Regul Sci. 2016 Mar;50(2):155-168.

PMID: 27042398

 

Evaluation of the Relative Performance of Drug-Induced Skeletal Muscle Injury Biomarkers in Rats.

Burch PM, Greg Hall D, Walker EG, Bracken W, Giovanelli R, Goldstein R, Higgs RE, King NM, Lane P, Sauer JM, Michna L, Muniappa N, Pritt ML, Vlasakova K, Watson DE, Wescott D, Zabka TS, Glaab WE.

Toxicol Sci. 2016 Mar;150(1):247-56. doi: 10.1093/toxsci/kfv328.

PMID: 26721300

 

Practical Ni-Catalyzed Aryl-Alkyl Cross-Coupling of Secondary Redox-Active Esters.

Cornella J, Edwards JT, Qin T, Kawamura S, Wang J, Pan CM, Gianatassio R, Schmidt M, Eastgate MD, Baran PS.

J Am Chem Soc. 2016 Feb 24;138(7):2174-7. doi: 10.1021/jacs.6b00250.

PMID: 26835704

 

Rationally engineered Troponin C modulates in vivo cardiac function and performance in health and disease.

Shettigar V, Zhang B, Little SC, Salhi HE, Hansen BJ, Li N, Zhang J, Roof SR, Ho HT, Brunello L, Lerch JK, Weisleder N, Fedorov VV, Accornero F, Rafael-Fortney JA, Gyorke S, Janssen PM, Biesiadecki BJ, Ziolo MT, Davis JP.

Nat Commun. 2016 Feb 24;7:10794. doi: 10.1038/ncomms10794.

PMID: 26908229

 

Optimization of microchip-based electrophoresis for monoclonal antibody product quality analysis revealed needs for extra surfactants during denaturation.

Cai H, Song Y, Zhang J, Shi T, Fu Y, Li R, Mussa N, Li ZJ.

J Pharm Biomed Anal. 2016 Feb 20;120:46-56. doi: 10.1016/j.jpba.2015.10.041.

PMID: 26704629

 

Regioselective Synthesis of Substituted 4-Alkylamino and 4-Arylaminophthalazin-1(2H)-ones.

Krishnananthan S, Smith D, Wu DR, Yip S, Gunaga P, Mathur A, Li J.

J Org Chem. 2016 Feb 19;81(4):1520-6. doi: 10.1021/acs.joc.5b02652.

PMID:26795884

 

Incidence of venous thromboembolism in France: a retrospective analysis of a national insurance claims database.

Bouée S, Emery C, Samson A, Gourmelen J, Bailly C, Cotté FE.

Thromb J. 2016 Feb 19;14:4. doi: 10.1186/s12959-016-0078-0.

PMID: 26900350

 

Isomerization and Oxidation in the Complementarity-Determining Regions of a Monoclonal Antibody: A Study of the Modification-Structure-Function Correlations by Hydrogen-Deuterium Exchange Mass Spectrometry.

Yan Y, Wei H, Fu Y, Jusuf S, Zeng M, Ludwig R, Krystek SR Jr, Chen G, Tao L, Das TK.

Anal Chem. 2016 Feb 16;88(4):2041-50. doi: 10.1021/acs.analchem.5b02800.

PMID: 26824491

 

Synthesis and SAR of calcitonin gene-related peptide (CGRP) antagonists containing substituted aryl-piperazines and piperidines.

Civiello RL, Han X, Beno BR, Chaturvedula PV, Herbst JJ, Xu C, Conway CM, Macor JE, Dubowchik GM.

Bioorg Med Chem Lett. 2016 Feb 15;26(4):1229-32. doi: 10.1016/j.bmcl.2016.01.026.

PMID: 26832218

 

Decreased use of glucocorticoids in biological-experienced patients with rheumatoid arthritis who initiated intravenous abatacept: results from the 2-year ACTION study.

Alten R, Nüßlein H, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Pavelka K, Chartier M, Poncet C, Rauch C, Elbez Y, Le Bars M.

RMD Open. 2016 Feb 15;2(1):e000228. doi: 10.1136/rmdopen-2015-000228.

PMID: 26925253

 

Discovery of Isonicotinamides as Highly Selective, Brain Penetrable, and Orally Active Glycogen Synthase Kinase-3 Inhibitors.

Luo G, Chen L, Burton CR, Xiao H, Sivaprakasam P, Krause CM, Cao Y, Liu N, Lippy J, Clarke WJ, Snow K, Raybon J, Arora V, Pokross M, Kish K, Lewis HA, Langley DR, Macor JE, Dubowchik GM.

J Med Chem. 2016 Feb 11;59(3):1041-51. doi: 10.1021/acs.jmedchem.5b01550.

PMID: 26751161

 

From analytical methods to large scale chiral supercritical fluid chromatography using chlorinated chiral stationary phases.

Wu DR, Yip SH, Li P, Sun D, Mathur A.

J Chromatogr A. 2016 Feb 5;1432:122-31. doi: 10.1016/j.chroma.2015.12.072.

PMID: 26768405

 

A highly sensitive and selective LC-MS/MS method to quantify asunaprevir, an HCV NS3 protease inhibitor, in human plasma in support of pharmacokinetic studies.

Kandoussi H, Jiang H, Zeng J, Zheng N, Kadiyala P, Eley T, He B, Garimella T, Demers R, Cojocaru L, Aubry AF, Arnold ME.

J Pharm Biomed Anal. 2016 Feb 5;119:145-51. doi: 10.1016/j.jpba.2015.11.028.

PMID: 26683987

 

Nitroarenes as Antitubercular Agents: Stereoelectronic Modulation to Mitigate Mutagenicity.

Landge S, Ramachandran V, Kumar A, Neres J, Murugan K, Sadler C, Fellows MD, Humnabadkar V, Vachaspati P, Raichurkar A, Sharma S, Ravishankar S, Guptha S, Sambandamurthy VK, Balganesh TS, Ugarkar BG, Balasubramanian V, Bandodkar BS, Panda M.

ChemMedChem. 2016 Feb 4;11(3):331-9. doi: 10.1002/cmdc.201500462.

PMID: 26751718

 

Immunogenicity to Biotherapeutics - The Role of Anti-drug Immune Complexes.

Krishna M, Nadler SG.

Front Immunol. 2016 Feb 2;7:21. doi: 10.3389/fimmu.2016.00021. Review.

PMID: 26870037

 

Crystal structure of microtubule affinity-regulating kinase 4 catalytic domain in complex with a pyrazolopyrimidine inhibitor.

Sack JS, Gao M, Kiefer SE, Myers JE Jr, Newitt JA, Wu S, Yan C.

Acta Crystallogr F Struct Biol Commun. 2016 Feb;72(Pt 2):129-34. doi: 10.1107/S2053230X15024747.

PMID: 26841763

 

Usability and Acceptability of the Abatacept Pre-Filled Autoinjector for the Subcutaneous Treatment of Rheumatoid Arthritis.

Schiff M, Koo J, Jin E, Schiller E, Day A, Stevens R, Laskar C.

Adv Ther. 2016 Feb;33(2):199-213. doi: 10.1007/s12325-016-0286-9.

PMID: 26833303

 

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

Pencina MJ, Louzao DM, McCourt BJ, Adams MR, Tayyabkhan RH, Ronco P, Peterson ED.

Am Heart J. 2016 Feb;172:64-9. doi: 10.1016/j.ahj.2015.11.002. Review.

PMID: 26856217

 

Surgical Resection Preferences and Perceptions among Medical Oncologists Treating Liver Metastases from Colorectal Cancer.

Choti MA, Thomas M, Wong SL, Eaddy M, Pawlik TM, Hirose K, Weiss MJ, Kish J, Green MR.

Ann Surg Oncol. 2016 Feb;23(2):375-81. doi: 10.1245/s10434-015-4925-1.

PMID: 26561404

 

Boston Society's 11th Annual Applied Pharmaceutical Analysis conference.

Lee V, Liu A, Groeber E, Moghaddam M, Schiller J, Tweed JA, Walker GS.

Bioanalysis. 2016 Feb;8(4):259-64. doi: 10.4155/bio.15.250.

PMID: 26853375

 

Absolute quantification of imipramine and its metabolites in vivo utilizing calibrators from radiolabeled in vitro incubations.

Bhutani P, Shah D, Varkhede N, Mandlekar S, Chacko S, Subramanian M.

Bioanalysis. 2016 Feb;8(4):297-309. doi: 10.4155/bio.15.259.

PMID: 26847656

 

LC-MS/MS multiplexed assay for the quantitation of a therapeutic protein BMS-986089 and the target protein Myostatin.

Zhu Y, D'Arienzo C, Lou Z, Kozhich A, Madireddi M, Chimalakonda A, Tymiak A, Olah TV.

Bioanalysis. 2016 Feb;8(3):193-204. doi: 10.4155/bio.15.238.

PMID: 26811930

 

Ultrasensitive quantitative LC-MS/MS of an inhibitor of apoptosis protein's antagonist in plasma using protein target affinity extraction.

Discenza LN, Cornelius G, Gan J, Szapiel N, Talbott RL, Chaudhry C, Roy A, Borzilleri RM, Vuppugalla R, Stefanski K, Moore R, D'Arienzo CJ, Olah TV, Mehl JT.

Bioanalysis. 2016 Feb;8(4):265-74. doi: 10.4155/bio.15.246.

PMID: 26807991

 

Discovery and preclinical evaluation of potent, orally bioavailable, metabolically stable cyclopropylindolobenzazepine acylsulfonamides as thumb site 1 inhibitors of the hepatitis c virus NS5B RNA-dependent, RNA polymerase.

Hewawasam P, Tu Y, Gao M, Hanumegowda U, Knipe J, Lemm JA, Parker DD, Rigat KL, Roberts SB, Meanwell NA, Kadow JF.

Bioorg Med Chem Lett. 2016 Feb 1;26(3):936-40. doi: 10.1016/j.bmcl.2015.12.058.

PMID: 26747393

 

A Developmental Toxicology Assay Platform for Screening Teratogenic Liability of Pharmaceutical Compounds.

Augustine-Rauch K, Zhang CX, Panzica-Kelly JM.

Birth Defects Res B Dev Reprod Toxicol. 2016 Feb;107(1):4-20. doi: 10.1002/bdrb.21168.

PMID: 26729651

 

Predicting analysis times in randomized clinical trials with cancer immunotherapy.

Chen TT.

BMC Med Res Methodol. 2016 Feb 1;16:12. doi: 10.1186/s12874-016-0117-3.

PMID: 26830911

 

Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.

Swallow E, Song J, Yuan Y, Kalsekar A, Kelley C, Peeples M, Mu F, Ackerman P, Signorovitch J.

Clin Ther. 2016 Feb;38(2):404-12. doi: 10.1016/j.clinthera.2015.12.017. Review.

PMID: 26839044

 

Pharmacokinetics of Weekly Paclitaxel and Feasibility of Dexamethasone Taper in Japanese Patients with Advanced Non-small Cell Lung Cancer.

Nokihara H, Yamamoto N, Ohe Y, Hiraoka M, Tamura T.

Clin Ther. 2016 Feb;38(2):338-47. doi: 10.1016/j.clinthera.2015.12.009.

PMID: 26774841

 

Cynomolgus Monkey as a Clinically Relevant Model to Study Transport Involving Renal Organic Cation Transporters: In Vitro and In Vivo Evaluation.

Shen H, Liu T, Jiang H, Titsch C, Taylor K, Kandoussi H, Qiu X, Chen C, Sukrutharaj S, Kuit K, Mintier G, Krishnamurthy P, Fancher RM, Zeng J, Rodrigues AD, Marathe P, Lai Y.

Drug Metab Dispos. 2016 Feb;44(2):238-49. doi: 10.1124/dmd.115.066852.

PMID: 26608080

 

The cost-effectiveness of daclatasvir-based regimens for the treatment of hepatitis C virus genotypes 1 and 4 in the UK.

McEwan P, Bennett H, Ward T, Webster S, Gordon J, Kalsekar A, Yuan Y, Brenner M.

Eur J Gastroenterol Hepatol. 2016 Feb;28(2):173-80. doi: 10.1097/MEG.0000000000000510.

PMID: 26545086

 

A phase I trial of pegylated liposomal doxorubicin (PLD), carboplatin, bevacizumab and veliparib in recurrent, platinum-sensitive ovarian, primary peritoneal, and fallopian tube cancer: An NRG Oncology/Gynecologic Oncology Group study.

Landrum LM, Brady WE, Armstrong DK, Moore KN, DiSilvestro PA, O'Malley DM, Tenney ME, Rose PG, Fracasso PM.

Gynecol Oncol. 2016 Feb;140(2):204-9. doi: 10.1016/j.ygyno.2015.11.024.

PMID: 26616225

 

Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B.

Jonas MM, Chang MH, Sokal E, Schwarz KB, Kelly D, Kim KM, Ling SC, Rosenthal P, Oraseanu D, Reynolds L, Thiry A, Ackerman P.

Hepatology. 2016 Feb;63(2):377-87. doi: 10.1002/hep.28015.

PMID: 26223345

 

Coupling Laser Diode Thermal Desorption with Acoustic Sample Deposition to Improve Throughput of Mass Spectrometry-Based Screening.

Haarhoff Z, Wagner A, Picard P, Drexler DM, Zvyaga T, Shou W.

J Biomol Screen. 2016 Feb;21(2):165-75. doi: 10.1177/1087057115607184.

PMID: 26420787

 

Treatment Outcomes With First-line Therapies With Entecavir and Tenofovir in Treatment-Naive Chronic Hepatitis B Patients in a Routine Clinical Practice.

Ha NB, Trinh HN, Rosenblatt L, Nghiem D, Nguyen MH.

J Clin Gastroenterol. 2016 Feb;50(2):169-74. doi: 10.1097/MCG.0000000000000345.

PMID: 26018133

 

Immune Checkpoint inhibitors: An introduction to the next-generation cancer immunotherapy.

Lee L, Gupta M, Sahasranaman S.

J Clin Pharmacol. 2016 Feb;56(2):157-69. doi: 10.1002/jcph.591. Review.

PMID: 26183909

 

Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.

Liu L, Bello A, Dresser MJ, Heald D, Komjathy SF, O'Mara E, Rogge M, Stoch SA, Robertson SM.

J Clin Pharmacol. 2016 Feb;56(2):143-51. doi: 10.1002/jcph.562. Review.

PMID: 26044116

 

Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection.

Zeuzem S, Hézode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourlière M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team..

J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024.

PMID: 26453968

 

Acoustic Sample Deposition MALDI-MS (ASD-MALDI-MS): A Novel Process Flow for Quality Control Screening of Compound Libraries.

Chin J, Wood E, Peters GS, Drexler DM.

J Lab Autom. 2016 Feb;21(1):204-7. doi: 10.1177/2211068215594769.

PMID: 26203056

 

Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound With Region-Dependent Absorption.

Kesisoglou F, Balakrishnan A, Manser K.

J Pharm Sci. 2016 Feb;105(2):722-8. doi: 10.1002/jps.24674.

PMID: 26457884

 

Evidence for Classical Cholinergic Toxicity Associated with Selective Activation of M1 Muscarinic Receptors.

Alt A, Pendri A, Bertekap RL Jr, Li G, Benitex Y, Nophsker M, Rockwell KL, Burford NT, Sum CS, Chen J, Herbst JJ, Ferrante M, Hendricson A, Cvijic ME, Westphal RS, O'Connell J, Banks M, Zhang L, Gentles RG, Jenkins S, Loy J, Macor JE.

J Pharmacol Exp Ther. 2016 Feb;356(2):293-304. doi: 10.1124/jpet.115.226910.

PMID: 26582730

 

Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis.

Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H.

J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831.

PMID: 26669919

 

Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients.

Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF.

Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964.

PMID: 26473667

 

STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies.

Tomlinson L, Ramaiah L, Tripathi NK, Barlow VG, Vitsky A, Poitout-Belissent FM, Bounous DI, Ennulat D.

Toxicol Pathol. 2016 Feb;44(2):163-72. doi: 10.1177/0192623315624165.

PMID: 26879687

 

Belatacept and Long-Term Outcomes in Kidney Transplantation.

Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP.

N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med. 2016 Feb 18;374(7):698.

PMID: 26816011

 

Antroquinonol A: Scalable Synthesis and Preclinical Biology of a Phase 2 Drug Candidate.

Villaume MT, Sella E, Saul G, Borzilleri RM, Fargnoli J, Johnston KA, Zhang H, Fereshteh MP, Dhar TG, Baran PS.

ACS Cent Sci. 2016 Jan 27;2(1):27-31. doi: 10.1021/acscentsci.5b00345.

PMID: 27163023

 

Channel Gating Regulation by the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) First Cytosolic Loop.

Ehrhardt A, Chung WJ, Pyle LC, Wang W, Nowotarski K, Mulvihill CM, Ramjeesingh M, Hong J, Velu SE, Lewis HA, Atwell S, Aller S, Bear CE, Lukacs GL, Kirk KL, Sorscher EJ.

J Biol Chem. 2016 Jan 22;291(4):1854-65. doi: 10.1074/jbc.M115.704809.

PMID: 26627831

 

Identification and Preclinical Pharmacology of BMS-986104: A Differentiated S1P1 Receptor Modulator in Clinical Trials.

Dhar TG, Xiao HY, Xie J, Lehman-McKeeman LD, Wu DR, Dabros M, Yang X, Taylor TL, Zhou XD, Heimrich EM, Thomas R, McIntyre KW, Warrack B, Shi H, Levesque PC, Zhu JL, Hennan J, Balimane P, Yang Z, Marino AM, Cornelius G, D'Arienzo CJ, Mathur A, Shen DR, Cvijic ME, Salter-Cid L, Barrish JC, Carter PH, Dyckman AJ.

ACS Med Chem Lett. 2016 Jan 19;7(3):283-8. doi: 10.1021/acsmedchemlett.5b00448.

PMID: 26985316

 

Label-Free Bottom-Up Proteomic Workflow for Simultaneously Assessing the Target Specificity of Covalent Drug Candidates and Their Off-Target Reactivity to Selected Proteins.

Yang Y, Shu YZ, Humphreys WG.

Chem Res Toxicol. 2016 Jan 19;29(1):109-16. doi: 10.1021/acs.chemrestox.5b00460.

PMID: 26675335

 

Novel technologies and emerging biomarkers for personalized cancer immunotherapy.

Yuan J, Hegde PS, Clynes R, Foukas PG, Harari A, Kleen TO, Kvistborg P, Maccalli C, Maecker HT, Page DB, Robins H, Song W, Stack EC, Wang E, Whiteside TL, Zhao Y, Zwierzina H, Butterfield LH, Fox BA.

J Immunother Cancer. 2016 Jan 19;4:3. doi: 10.1186/s40425-016-0107-3. Review.

PMID: 26788324

 

Ulocuplumab (BMS-936564 / MDX1338): a fully human anti-CXCR4 antibody induces cell death in chronic lymphocytic leukemia mediated through a reactive oxygen species-dependent pathway.

Kashyap MK, Kumar D, Jones H, Amaya-Chanaga CI, Choi MY, Melo-Cardenas J, Ale-Ali A, Kuhne MR, Sabbatini P, Cohen LJ, Shelat SG, Rassenti LZ, Kipps TJ, Cardarelli PM, Castro JE.

Oncotarget. 2016 Jan 19;7(3):2809-22. doi: 10.18632/oncotarget.6465.

PMID: 26646452

 

Novel phenylalanine derived diamides as Factor XIa inhibitors.

Smith LM 2nd, Orwat MJ, Hu Z, Han W, Wang C, Rossi KA, Gilligan PJ, Pabbisetty KB, Osuna H, Corte JR, Rendina AR, Luettgen JM, Wong PC, Narayanan R, Harper TW, Bozarth JM, Crain EJ, Wei A, Ramamurthy V, Morin PE, Xin B, Zheng J, Seiffert DA, Quan ML, Lam PY, Wexler RR, Pinto DJ.

Bioorg Med Chem Lett. 2016 Jan 15;26(2):472-8. doi: 10.1016/j.bmcl.2015.11.089.

PMID: 26704266

 

Discovery and synthesis of cyclohexenyl derivatives as modulators of CC chemokine receptor 2 activity.

Brown GD, Shi Q, Delucca GV, Batt DG, Galella MA, Cvijic ME, Liu RQ, Qiu F, Zhao Q, Barrish JC, Carter PH.

Bioorg Med Chem Lett. 2016 Jan 15;26(2):662-6. doi: 10.1016/j.bmcl.2015.11.051.

PMID: 26631321

 

NS5A Sequence Heterogeneity and Mechanisms of Daclatasvir Resistance in Hepatitis C Virus Genotype 4 Infection.

Zhou N, Hernandez D, Ueland J, Yang X, Yu F, Sims K, Yin PD, McPhee F.

J Infect Dis. 2016 Jan 15;213(2):206-15. doi: 10.1093/infdis/jiv379.

PMID: 26170396

 

Bioequivalence of saxagliptin/dapagliflozin fixed-dose combination tablets compared with coadministration of the individual tablets to healthy subjects.

Vakkalagadda B, Vetter ML, Rana J, Smith CH, Huang J, Karkas J, Boulton DW, LaCreta F.

Pharmacol Res Perspect. 2016 Jan 12;3(6):e00201. doi: 10.1002/prp2.201.

PMID: 27022473

 

Targeting the BACE1 Active Site Flap Leads to a Potent Inhibitor That Elicits Robust Brain Aβ Reduction in Rodents.

Wu YJ, Guernon J, Yang F, Snyder L, Shi J, Mcclure A, Rajamani R, Park H, Ng A, Lewis H, Chang C, Camac D, Toyn JH, Ahlijanian MK, Albright CF, Macor JE, Thompson LA.

ACS Med Chem Lett. 2016 Jan 11;7(3):271-6. doi: 10.1021/acsmedchemlett.5b00432.

PMID: 26985314

 

Ligand-Promoted Borylation of C(sp(3))-H Bonds with Palladium(II) Catalysts.

He J, Jiang H, Takise R, Zhu RY, Chen G, Dai HX, Dhar TG, Shi J, Zhang H, Cheng PT, Yu JQ.

Angew Chem Int Ed Engl. 2016 Jan 11;55(2):785-9. doi: 10.1002/anie.201509996.

PMID: 26611496

 

TIGIT Marks Exhausted T Cells, Correlates with Disease Progression, and Serves as a Target for Immune Restoration in HIV and SIV Infection.

Chew GM, Fujita T, Webb GM, Burwitz BJ, Wu HL, Reed JS, Hammond KB, Clayton KL, Ishii N, Abdel-Mohsen M, Liegler T, Mitchell BI, Hecht FM, Ostrowski M, Shikuma CM, Hansen SG, Maurer M, Korman AJ, Deeks SG, Sacha JB, Ndhlovu LC.

PLoS Pathog. 2016 Jan 7;12(1):e1005349. doi: 10.1371/journal.ppat.1005349.

PMID: 26741490

 

Discovery and Preclinical Evaluation of BMS-955829, a Potent Positive Allosteric Modulator of mGluR5.

Yang F, Snyder LB, Balakrishnan A, Brown JM, Sivarao DV, Easton A, Fernandes A, Gulianello M, Hanumegowda UM, Huang H, Huang Y, Jones KM, Li YW, Matchett M, Mattson G, Miller R, Santone KS, Senapati A, Shields EE, Simutis FJ, Westphal R, Whiterock VJ, Bronson JJ, Macor JE, Degnan AP.

ACS Med Chem Lett. 2016 Jan 4;7(3):289-93. doi: 10.1021/acsmedchemlett.5b00450.

PMID: 26985317

 

Dissolution of Danazol Amorphous Solid Dispersions: Supersaturation and Phase Behavior as a Function of Drug Loading and Polymer Type.

Jackson MJ, Kestur US, Hussain MA, Taylor LS.

Mol Pharm. 2016 Jan 4;13(1):223-31. doi: 10.1021/acs.molpharmaceut.5b00652.

PMID: 26618718

 

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.

Jani D, Allinson J, Berisha F, Cowan KJ, Devanarayan V, Gleason C, Jeromin A, Keller S, Khan MU, Nowatzke B, Rhyne P, Stephen L.

AAPS J. 2016 Jan;18(1):1-14. doi: 10.1208/s12248-015-9820-y. Review.

PMID: 26377333

 

Warfarin Discontinuation in Patients With Unprovoked Venous Thromboembolism: A Large US Insurance Database Analysis.

Xie L, Liu X, Phatak H, Mardekian J, Tan W, Baser O, Ramacciotti E.

Am J Ther. 2016 Nov/Dec;23(6):e1744-e1753.

PMID: 26214203

 

Overview on biotherapeutic proteins: impact on bioanalysis.

Zhang YJ, Luo L, Desai DD.

Bioanalysis. 2016;8(1):1-9. doi: 10.4155/bio.15.224. Review.

PMID: 26648322

 

Determination of kynurenic acid in rat cerebrospinal fluid by HPLC with fluorescence detection.

Bao Y, Luchetti D, Schaeffer E, Cutrone J.

Biomed Chromatogr. 2016 Jan;30(1):62-7. doi: 10.1002/bmc.3492.

PMID: 25963282

 

Inhibitors of HIV-1 attachment: The discovery and structure-activity relationships of tetrahydroisoquinolines as replacements for the piperazine benzamide in the 3-glyoxylyl 6-azaindole pharmacophore.

Swidorski JJ, Liu Z, Yin Z, Wang T, Carini DJ, Rahematpura S, Zheng M, Johnson K, Zhang S, Lin PF, Parker DD, Li W, Meanwell NA, Hamann LG, Regueiro-Ren A.

Bioorg Med Chem Lett. 2016 Jan 1;26(1):160-7. doi: 10.1016/j.bmcl.2015.11.009.

PMID: 26584882

 

The use of 'Omics technology to rationally improve industrial mammalian cell line performance.

Lewis AM, Abu-Absi NR, Borys MC, Li ZJ.

Biotechnol Bioeng. 2016 Jan;113(1):26-38. doi: 10.1002/bit.25673. Review.

PMID: 26059229

 

Effects of dapagliflozin on blood pressure in hypertensive diabetic patients on renin-angiotensin system blockade.

Weber MA, Mansfield TA, Alessi F, Iqbal N, Parikh S, Ptaszynska A.

Blood Press. 2016;25(2):93-103. doi: 10.3109/08037051.2015.1116258.

PMID: 26623980

 

First-in-human multicenter phase I study of BMS-936561 (MDX-1203), an antibody-drug conjugate targeting CD70.

Owonikoko TK, Hussain A, Stadler WM, Smith DC, Kluger H, Molina AM, Gulati P, Shah A, Ahlers CM, Cardarelli PM, Cohen LJ.

Cancer Chemother Pharmacol. 2016 Jan;77(1):155-62. doi: 10.1007/s00280-015-2909-2.

PMID: 26576779

 

Cancer Immunotherapy with Immunomodulatory Anti-CD137 and Anti-PD-1 Monoclonal Antibodies Requires BATF3-Dependent Dendritic Cells.

Sánchez-Paulete AR, Cueto FJ, Martínez-López M, Labiano S, Morales-Kastresana A, Rodríguez-Ruiz ME, Jure-Kunkel M, Azpilikueta A, Aznar MA, Quetglas JI, Sancho D, Melero I.

Cancer Discov. 2016 Jan;6(1):71-9. doi: 10.1158/2159-8290.CD-15-0510.

PMID: 26493961

 

Real-World Medical Cost Avoidance When New Oral Anticoagulants are Used Versus Warfarin for Venous Thromboembolism in the United States.

Amin A, Bruno A, Trocio J, Lin J, Lingohr-Smith M.

Clin Appl Thromb Hemost. 2016 Jan;22(1):5-11. doi: 10.1177/1076029615585991. Review.

PMID: 25993994

 

Safety, pharmacokinetics, and pharmacodynamics of PD 0348292, an oral, direct factor Xa inhibitor, after single and multiple dosings in healthy subjects.

Xuan D, McBride S, Wastall P, Porcari A, DiCarlo L, Boyd RA.

Clin Pharmacol Drug Dev. 2016 Jan;5(1):13-26. doi: 10.1002/cpdd.232.

PMID: 27119575

 

Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Boulton DW, Chang M, Griffen SC, Kitaura C, Lubin S, Pollack A, LaCreta F.

Clin Ther. 2016 Jan 1;38(1):99-109. doi: 10.1016/j.clinthera.2015.11.010.

PMID: 26682500

 

An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants.

Deitelzweig S, Bruno A, Trocio J, Tate N, Gupta K, Lin J, Lingohr-Smith M.

Curr Med Res Opin. 2016;32(3):573-82. doi: 10.1185/03007995.2015.1131676.

PMID: 26652179

 

Methods applied in cost-effectiveness models for treatment strategies in type 2 diabetes mellitus and their use in Health Technology Assessments: a systematic review of the literature from 2008 to 2013.

Charokopou M, Sabater FJ, Townsend R, Roudaut M, McEwan P, Verheggen BG.

Curr Med Res Opin. 2016;32(2):207-18. doi: 10.1185/03007995.2015.1102722. Review.

PMID: 26473650

 

Warfarin time in therapeutic range and its impact on healthcare resource utilization and costs among patients with nonvalvular atrial fibrillation.

Deitelzweig S, Evans M, Hillson E, Trocio J, Bruno A, Tan W, Lingohr-Smith M, Singh P, Lin J.

Curr Med Res Opin. 2016;32(1):87-94. doi: 10.1185/03007995.2015.1103217.

PMID: 26451675

 

A quality by design approach to scale-up of high-shear wet granulation process.

Pandey P, Badawy S.

Drug Dev Ind Pharm. 2016;42(2):175-89. doi: 10.3109/03639045.2015.1100199. Review.

PMID: 26489403

 

Assessing impact of manufacturing and package configurations to photosensitive compounds.

Carvalho TC, Escotet ML, Lin J, Sprockel OL.

Drug Dev Ind Pharm. 2016;42(6):936-44. doi: 10.3109/03639045.2015.1091472.

PMID: 26460067

 

Comparison of integrated genotoxicity endpoints in rats after acute and subchronic oral doses of 4-nitroquinoline-1-oxide.

Roberts DJ, McKeon M, Xu Y, Stankowski LF Jr.

Environ Mol Mutagen. 2016 Jan;57(1):17-27. doi: 10.1002/em.21981.

PMID: 26407646

 

A roadmap to improve the quality of atrial fibrillation management: proceedings from the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference.

Kirchhof P, Breithardt G, Bax J, Benninger G, Blomstrom-Lundqvist C, Boriani G, Brandes A, Brown H, Brueckmann M, Calkins H, Calvert M, Christoffels V, Crijns H, Dobrev D, Ellinor P, Fabritz L, Fetsch T, Freedman SB, Gerth A, Goette A, Guasch E, Hack G, Haegeli L, Hatem S, Haeusler KG, Heidbüchel H, Heinrich-Nols J, Hidden-Lucet F, Hindricks G, Juul-Möller S, Kääb S, Kappenberger L, Kespohl S, Kotecha D, Lane DA, Leute A, Lewalter T, Meyer R, Mont L, Münzel F, Nabauer M, Nielsen JC, Oeff M, Oldgren J, Oto A, Piccini JP, Pilmeyer A, Potpara T, Ravens U, Reinecke H, Rostock T, Rustige J, Savelieva I, Schnabel R, Schotten U, Schwichtenberg L, Sinner MF, Steinbeck G, Stoll M, Tavazzi L, Themistoclakis S, Tse HF, Van Gelder IC, Vardas PE, Varpula T, Vincent A, Werring D, Willems S, Ziegler A, Lip GY, Camm AJ.

Europace. 2016 Jan;18(1):37-50. doi: 10.1093/europace/euv304. Review.

PMID: 26481149

 

Hepatic drug transporters: the journey so far.

Riley RJ, Foley SA, Barton P, Soars MG, Williamson B.

Expert Opin Drug Metab Toxicol. 2016;12(2):201-16. doi: 10.1517/17425255.2016.1132308. Review.

PMID: 26670591

 

Strategies to distinguish new synthetic cannabinoid FUBIMINA (BIM-2201) intake from its isomer THJ-2201: metabolism of FUBIMINA in human hepatocytes.

Diao X, Scheidweiler KB, Wohlfarth A, Zhu M, Pang S, Huestis MA.

Forensic Toxicol. 2016;34:256-267.

PMID: 27547265

 

A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm.

Fermini B, Hancox JC, Abi-Gerges N, Bridgland-Taylor M, Chaudhary KW, Colatsky T, Correll K, Crumb W, Damiano B, Erdemli G, Gintant G, Imredy J, Koerner J, Kramer J, Levesque P, Li Z, Lindqvist A, Obejero-Paz CA, Rampe D, Sawada K, Strauss DG, Vandenberg JI.

J Biomol Screen. 2016 Jan;21(1):1-11. doi: 10.1177/1087057115594589. Review.

PMID: 26170255

 

Testing for parallelism in the heteroscedastic four-parameter logistic model.

Sidik K, Jonkman JN.

J Biopharm Stat. 2016;26(2):250-68. doi: 10.1080/10543406.2014.1003432.

PMID: 25629201

 

Management of epidermal growth factor receptor inhibitor-associated rash: a systematic review.

Brown J, Su Y, Nelleson D, Shankar P, Mayo C.

J Community Support Oncol. 2016 Jan;14(1):21-8. doi: 10.12788/jcso.0193.

PMID: 26870839

 

Randomized comparison of daclatasvir + asunaprevir versus telaprevir + peginterferon/ribavirin in Japanese hepatitis C virus patients.

Kumada H, Suzuki F, Suzuki Y, Toyota J, Karino Y, Chayama K, Kawakami Y, Fujiyama S, Ito T, Itoh Y, Tamura E, Ueki T, Ishikawa H, Hu W, McPhee F, Linaberry M, Hughes E.

J Gastroenterol Hepatol. 2016 Jan;31(1):14-22. doi: 10.1111/jgh.13073.

PMID: 26252875

 

Persistence, adherence, and all-cause healthcare costs in atazanavir- and darunavir-treated patients with human immunodeficiency virus in a real-world setting.

Farr AM, Johnston SS, Ritchings C, Brouillette M, Rosenblatt L.

J Med Econ. 2016;19(4):386-96. doi: 10.3111/13696998.2015.1128942.

PMID: 26640980

 

Cost-effectiveness analysis of second-line tyrosine kinase inhibitor treatment for chronic myelogenous leukemia.

Whalen J, Stillman I, Ambavane A, Felber E, Makenbaeva D, Bolinder B.

J Med Econ. 2016;19(5):445-61. doi: 10.3111/13696998.2015.1126285.

PMID: 26613118

 

A retrospective study of persistence, adherence, and health economic outcomes of fixed-dose combination vs. loose-dose combination of oral anti-diabetes drugs.

Lokhandwala T, Smith N, Sternhufvud C, Sörstadius E, Lee WC, Mukherjee J.

J Med Econ. 2016;19(3):203-12. doi: 10.3111/13696998.2015.1109518.

PMID: 26473990

 

Process Analytical Technology for High Shear Wet Granulation: Wet Mass Consistency Reported by In-Line Drag Flow Force Sensor Is Consistent With Powder Rheology Measured by At-Line FT4 Powder Rheometer.

Narang AS, Sheverev V, Freeman T, Both D, Stepaniuk V, Delancy M, Millington-Smith D, Macias K, Subramanian G.

J Pharm Sci. 2016 Jan;105(1):182-7. doi: 10.1016/j.xphs.2015.11.030.

PMID: 26852853

 

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

Badawy SI, Narang AS, LaMarche KR, Subramanian GA, Varia SA, Lin J, Stevens T, Shah PA.

J Pharm Sci. 2016 Jan;105(1):168-81. doi: 10.1016/j.xphs.2015.11.023.

PMID: 26852852

 

Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial.

Gupta SK, McComsey GA, Lombaard J, Echevarría J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M.

Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3.

PMID: 26762988

 

Lymphoma in acquired generalized lipodystrophy.

Brown RJ, Chan JL, Jaffe ES, Cochran E, DePaoli AM, Gautier JF, Goujard C, Vigouroux C, Gorden P.

Leuk Lymphoma. 2016;57(1):45-50. doi: 10.3109/10428194.2015.1040015.

PMID: 25864863

 

Multi-Site N-glycan mapping study 1: Capillary electrophoresis - laser induced fluorescence.

Szekrényes Á, Park SS, Santos M, Lew C, Jones A, Haxo T, Kimzey M, Pourkaveh S, Szabó Z, Sosic Z, Feng P, Váradi C, de l'Escaille F, Falmagne JB, Sejwal P, Niedringhaus T, Michels D, Freckleton G, Hamm M, Manuilov A, Schwartz M, Luo JK, van Dyck J, Leung PK, Olajos M, Gu Y, Gao K, Wang W, Wegstein J, Tep S, Guttman A.

MAbs. 2016;8(1):56-64. doi: 10.1080/19420862.2015.1107687.

PMID: 26466659

 

No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data.

Nkhoma ET, Coumbis J, Farr AM, Johnston SS, Chu BC, Rosenblatt LC, Seekins D, Villasis-Keever A.

Medicine (Baltimore). 2016 Jan;95(3):e2480. doi: 10.1097/MD.0000000000002480.

PMID: 26817882

 

Purification and Functional Reconstitution of Box H/ACA Ribonucleoprotein Particles.

Huang C, Wu G, Yu YT.

Methods Mol Biol. 2016;1421:97-109. doi: 10.1007/978-1-4939-3591-8_9.

PMID: 26965260

 

Negative Allosteric Modulators Selective for The NR2B Subtype of The NMDA Receptor Impair Cognition in Multiple Domains.

Weed MR, Bookbinder M, Polino J, Keavy D, Cardinal RN, Simmermacher-Mayer J, Cometa FN, King D, Thangathirupathy S, Macor JE, Bristow LJ.

Neuropsychopharmacology. 2016 Jan;41(2):568-77. doi: 10.1038/npp.2015.184.

PMID: 26105137

 

Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

Lu X, Lloyd DK, Klohr SE.

PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):39-50. doi: 10.5731/pdajpst.2015.006015.

PMID: 26889055

 

Effect of pepsin on maintaining the supersaturation of the HCl salt of a weakly basic drug: a case study.

Pinnamaneni S, Rinaldi FA, Jayawickrama DA, Li J, Dali MV.

Pharm Dev Technol. 2016;21(3):311-20. doi: 10.3109/10837450.2014.1003653.

PMID: 25708152

 

Reprint of "Potential seminal transport of pharmaceuticals to the conceptus".

Scialli AR, Bailey G, Beyer BK, Bøgh IB, Breslin WJ, Chen CL, DeLise AM, Hui JY, Moffat GJ, Stewart J, Thompson KE.

Reprod Toxicol. 2016 Jan;59:22-30. doi: 10.1016/j.reprotox.2016.01.005. Review.

PMID: 26854737

 

Assessment of cervical passage of vital dyes in pregnant, nonpregnant, and mated rats and mice.

Thompson KE, Rayhon SL, Bailey G, Delille P, McNerney ME.

Reprod Toxicol. 2016 Jan;59:1-7. doi: 10.1016/j.reprotox.2015.10.018.

PMID: 26546978

 

Evaluation of early fetal exposure to vaginally-administered metronidazole in pregnant cynomolgus monkeys.

Thompson KE, Newcomb DL, Moffat GJ, Zalikowski J, Chellman GJ, McNerney ME.

Reprod Toxicol. 2016 Jan;59:17-21. doi: 10.1016/j.reprotox.2015.10.013.

PMID: 26524246

 

Cardioprotection by Thymosin Beta 4.

Pipes GT, Yang J.

Vitam Horm. 2016;102:209-26. doi: 10.1016/bs.vh.2016.04.004.

PMID: 27450736

 

Characterization of ADME properties of [(14)C]asunaprevir (BMS-650032) in humans.

Gong J, Eley T, He B, Arora V, Philip T, Jiang H, Easter J, Humphreys WG, Iyer RA, Li W.

Xenobiotica. 2016;46(1):52-64. doi: 10.3109/00498254.2015.1048487.

PMID: 26153443

Measuring the sticking of mefenamic acid powders on stainless steel surface.

Wang Z, Shah UV, Olusanmi D, Narang AS, Hussain MA, Gamble JF, Tobyn MJ, Heng JY.

Int J Pharm. 2015 Dec 30;496(2):407-13. doi: 10.1016/j.ijpharm.2015.09.067.

PMID: 26456293

 

Synergistic Activity of Combined NS5A Inhibitors.

O'Boyle DR 2nd, Nower PT, Gao M, Fridell R, Wang C, Hewawasam P, Lopez O, Tu Y, Meanwell NA, Belema M, Roberts SB, Cockett M, Sun JH.

Antimicrob Agents Chemother. 2015 Dec 28;60(3):1573-83. doi: 10.1128/AAC.02639-15.

PMID: 26711745

 

Characterization and quantification of histidine degradation in therapeutic protein formulations by size exclusion-hydrophilic interaction two dimensional-liquid chromatography with stable-isotope labeling mass spectrometry.

Wang C, Chen S, Brailsford JA, Yamniuk AP, Tymiak AA, Zhang Y.

J Chromatogr A. 2015 Dec 24;1426:133-9. doi: 10.1016/j.chroma.2015.11.065.

PMID: 26674608

 

The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK.

Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D.

PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524.

PMID: 26700304

 

Genetic Architecture of Atherosclerosis in Mice: A Systems Genetics Analysis of Common Inbred Strains.

Bennett BJ, Davis RC, Civelek M, Orozco L, Wu J, Qi H, Pan C, Packard RR, Eskin E, Yan M, Kirchgessner T, Wang Z, Li X, Gregory JC, Hazen SL, Gargalovic PS, Lusis AJ.

PLoS Genet. 2015 Dec 22;11(12):e1005711. doi: 10.1371/journal.pgen.1005711. Erratum in: PLoS Genet. 2016 Mar;12(3):e1005913.

PMID: 26694027

 

Asymmetric Synthesis of Heterocyclic Analogues of a CGRP Receptor Antagonist for Treating Migraine.

Luo G, Chen L, Conway CM, Kostich W, Macor JE, Dubowchik GM.

Org Lett. 2015 Dec 18;17(24):5982-5. doi: 10.1021/acs.orglett.5b02921.

PMID: 26650258

 

General Method for the Preparation of Electron-Deficient Imidazo[1,2-a]pyridines and Related Heterocycles.

McDonald IM, Peese KM.

Org Lett. 2015 Dec 18;17(24):6002-5. doi: 10.1021/acs.orglett.5b02966.

PMID: 26598965

 

Post-pellet-digestion precipitation and solid phase extraction: A practical and efficient workflow to extract surrogate peptides for ultra-high performance liquid chromatography--tandem mass spectrometry bioanalysis of a therapeutic antibody in the low ng/mL range.

Gong C, Zheng N, Zeng J, Aubry AF, Arnold ME.

J Chromatogr A. 2015 Dec 11;1424:27-36. doi: 10.1016/j.chroma.2015.10.049.

PMID: 26525666

 

Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial.

Vinereanu D, Stevens SR, Alexander JH, Al-Khatib SM, Avezum A, Bahit MC, Granger CB, Lopes RD, Halvorsen S, Hanna M, Husted S, Hylek EM, Mărgulescu AD, Wallentin L, Atar D.

Eur Heart J. 2015 Dec 7;36(46):3268-75. doi: 10.1093/eurheartj/ehv447.

PMID: 26371113

 

Mitigation of Adverse Clinical Events of a Narrow Target Therapeutic Index Compound through Modified Release Formulation Design: An in Vitro, in Vivo, in Silico, and Clinical Pharmacokinetic Analysis.

Good DJ, Hartley R, Mathias N, Crison J, Tirucherai G, Timmins P, Hussain M, Haddadin R, Koo O, Nikfar F, Fung NK.

Mol Pharm. 2015 Dec 7;12(12):4434-44. doi: 10.1021/acs.molpharmaceut.5b00624.

PMID: 26536519

 

Discovery of the Selective CYP17A1 Lyase Inhibitor BMS-351 for the Treatment of Prostate Cancer.

Huang A, Jayaraman L, Fura A, Vite GD, Trainor GL, Gottardis MM, Spires TE, Spires VM, Rizzo CA, Obermeier MT, Elzinga PA, Todderud G, Fan Y, Newitt JA, Beyer SM, Zhu Y, Warrack BM, Goodenough AK, Tebben AJ, Doweyko AM, Gold DL, Balog A.

ACS Med Chem Lett. 2015 Dec 2;7(1):40-5. doi: 10.1021/acsmedchemlett.5b00310.

PMID: 26819663

 

Finite Element Method (FEM) Modeling of Freeze-drying: Monitoring Pharmaceutical Product Robustness During Lyophilization.

Chen X, Sadineni V, Maity M, Quan Y, Enterline M, Mantri RV.

AAPS PharmSciTech. 2015 Dec;16(6):1317-26. doi: 10.1208/s12249-015-0318-9.

PMID: 25791415

 

Anticipated Impact of Generic Imatinib Market Entry on the Costs of Tyrosine Kinase Inhibitors.

Bloudek LM, Makenbaeva D, Eaddy M.

Am Health Drug Benefits. 2015 Dec;8(9):472-80.

PMID: 26834933

 

The impact of dasatinib on pregnancy outcomes.

Cortes JE, Abruzzese E, Chelysheva E, Guha M, Wallis N, Apperley JF.

Am J Hematol. 2015 Dec;90(12):1111-5. doi: 10.1002/ajh.24186.

PMID: 26348106

 

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J.

Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226.

PMID: 26635247

 

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

Ackermann B, Neubert H, Hughes N, Garofolo F, Abberley L, Alley SC, Brown-Augsburger P, Bustard M, Chen LZ, Heinrich J, Katori N, Kaur S, Kirkovsky L, Laterza OF, Le Blaye O, Lévesque A, Santos GM, Olah T, Savoie N, Skelly M, Spitz S, Szapacs M, Tampal N, Wang J, Welink J, Wieling J, Haidar S, Vinter S, Whale E, Witte B.

Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214.

PMID: 26627049

 

So you think your assay is robust?

Aubry AF, Weng N.

Bioanalysis. 2015 Dec;7(23):2969-71. doi: 10.4155/bio.15.198. No abstract available.

PMID: 26616477

 

Altered expression of CDC42 signaling pathway components in cortical layer 3 pyramidal cells in schizophrenia.

Datta D, Arion D, Corradi JP, Lewis DA.

Biol Psychiatry. 2015 Dec 1;78(11):775-85. doi: 10.1016/j.biopsych.2015.03.030.

PMID: 25981171

 

Statistical Challenges in the Design of Late-Stage Cancer Immunotherapy Studies.

Mick R, Chen TT.

Cancer Immunol Res. 2015 Dec;3(12):1292-8. doi: 10.1158/2326-6066.CIR-15-0260. Review.

PMID: 26644449

 

Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab.

Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS.

Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

PMID: 26627641

 

Use of Real-World Claim Databases to Assess Prevalence of Comorbid Conditions Relevant to the Treatment of Chronic Myelogenous Leukemia Based on National Comprehensive Network Treatment Guidelines.

Jabbour E, Makenbaeva D, Lingohr-Smith M, Lin J.

Clin Lymphoma Myeloma Leuk. 2015 Dec;15(12):797-802. doi: 10.1016/j.clml.2015.09.008.

PMID: 26603185

 

Asunaprevir: A Review of Preclinical and Clinical Pharmacokinetics and Drug-Drug Interactions.

Eley T, Garimella T, Li W, Bertz RJ.

Clin Pharmacokinet. 2015 Dec;54(12):1205-22. doi: 10.1007/s40262-015-0299-6. Review.

PMID: 26177803

 

Cost-effectiveness Analysis of Apixaban against Warfarin for Stroke Prevention in Patients with Nonvalvular Atrial Fibrillation in Japan.

Kamae I, Hashimoto Y, Koretsune Y, Tanahashi N, Murata T, Phatak H, Liu LZ, Tang AC, Feng Wang P, Okumura K.

Clin Ther. 2015 Dec 1;37(12):2837-51. doi: 10.1016/j.clinthera.2015.10.007.

PMID: 26608819

 

Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study.

Simon D, de Pablos-Velasco P, Parhofer KG, Gönder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwège E, Bradley C.

Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007.

PMID: 26455870

 

Health state utilities associated with attributes of treatments for hepatitis C.

Matza LS, Sapra SJ, Dillon JF, Kalsekar A, Davies EW, Devine MK, Jordan JB, Landrian AS, Feeny DH.

Eur J Health Econ. 2015 Dec;16(9):1005-18. doi: 10.1007/s10198-014-0649-6.

PMID: 25481796

 

Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial.

Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT.

J Am Heart Assoc. 2015 Dec 1;4(12). pii: e002340. doi: 10.1161/JAHA.115.002340.

PMID: 26627879

 

Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

Rao MP, Halvorsen S, Wojdyla D, Thomas L, Alexander JH, Hylek EM, Hanna M, Bahit MC, Lopes RD, De Caterina R, Erol C, Goto S, Lanas F, Lewis BS, Husted S, Gersh BJ, Wallentin L, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Steering Committee and Investigators..

J Am Heart Assoc. 2015 Dec 1;4(12). pii: e002015. doi: 10.1161/JAHA.115.002015.

PMID: 26627878

 

The Risk for Cardiovascular Events Associated with Hyperlipdemia among Patients with and Without Rheumatoid Arthritis.

Nadkarni A, You M, Resuehr H, Curtis JR.

J Arthritis. 2015 Dec;4(4). pii: 178.

PMID: 26835182

 

Development of a Model Protein Interaction Pair as a Benchmarking Tool for the Quantitative Analysis of 2-Site Protein-Protein Interactions.

Yamniuk AP, Newitt JA, Doyle ML, Arisaka F, Giannetti AM, Hensley P, Myszka DG, Schwarz FP, Thomson JA, Eisenstein E.

J Biomol Tech. 2015 Dec;26(4):125-41. doi: 10.7171/jbt.15-2604-001.

PMID: 26543437

 

Comparison of Ensemble and Single Molecule Methods for Particle Characterization and Binding Analysis of a PEGylated Single-Domain Antibody.

Schneeweis LA, Obenauer-Kutner L, Kaur P, Yamniuk AP, Tamura J, Jaffe N, O'Mara BW, Lindsay S, Doyle M, Bryson J.

J Pharm Sci. 2015 Dec;104(12):4015-24. doi: 10.1002/jps.24624.

PMID: 26343417

 

Integrated Pharmacokinetic/Pharmacodynamic Analysis for Determining the Minimal Anticipated Biological Effect Level of a Novel Anti-CD28 Receptor Antagonist BMS-931699.

Yang Z, Wang H, Salcedo TW, Suchard SJ, Xie JH, Schneeweis LA, Fleener CA, Calore JD, Shi R, Zhang SX, Rodrigues AD, Car BD, Marathe PH, Nadler SG.

J Pharmacol Exp Ther. 2015 Dec;355(3):506-15. doi: 10.1124/jpet.115.227249.

PMID: 26442523

 

Memory re-differentiation and reduced lymphocyte activation in chronic HCV-infected patients receiving direct-acting antivirals.

Burchill MA, Golden-Mason L, Wind-Rotolo M, Rosen HR.

J Viral Hepat. 2015 Dec;22(12):983-91. doi: 10.1111/jvh.12465.

PMID: 26482547

 

Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b-2 dose-escalation study.

Richardson PG, Jagannath S, Moreau P, Jakubowiak AJ, Raab MS, Facon T, Vij R, White D, Reece DE, Benboubker L, Zonder J, Tsao LC, Anderson KC, Bleickardt E, Singhal AK, Lonial S; 1703 study investigators..

Lancet Haematol. 2015 Dec;2(12):e516-27. doi: 10.1016/S2352-3026(15)00197-0.

PMID: 26686406

 

Cause of death in patients with atrial fibrillation admitted to French hospitals in 2012: a nationwide database study.

Fauchier L, Samson A, Chaize G, Gaudin AF, Vainchtock A, Bailly C, Cotté FE.

Open Heart. 2015 Dec 1;2(1):e000290. doi: 10.1136/openhrt-2015-000290.

PMID: 26688739

 

Efavirenz Capsule Sprinkle and Liquid Formulations With Didanosine and Emtricitabine in HIV-1-infected Infants and Children 3 Months to 6 Years of Age: Study AI266-922.

Pavia-Ruz N, Rossouw M, Sáez-Llorens X, Bunupuradah T, Taylor M, Yang R, Sevinsky H, Krystal M, Lataillade M, Seekins D, Biguenet S.

Pediatr Infect Dis J. 2015 Dec;34(12):1355-60. doi: 10.1097/INF.0000000000000913.

PMID: 26379163

 

Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist.

Radawski C, Morrato E, Hornbuckle K, Bahri P, Smith M, Juhaeri J, Mol P, Levitan B, Huang HY, Coplan P, Li H; BRACE Special Interest Group..

Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1233-40. doi: 10.1002/pds.3859. Review.

PMID: 26456379

 

The role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG).

Tremaine L, Brian W, DelMonte T, Francke S, Groenen P, Johnson K, Li L, Pearson K, Marshall JC.

Pharmacogenomics. 2015 Dec;16(18):2055-67. doi: 10.2217/pgs.15.141. Review.

PMID: 26616152

 

Caring for relatives with lung cancer in Europe: an evaluation of caregivers' experience.

Jassem J, Penrod JR, Goren A, Gilloteau I.

Qual Life Res. 2015 Dec;24(12):2843-52. doi: 10.1007/s11136-015-1028-1.

PMID: 26068731

 

Potential seminal transport of pharmaceuticals to the conceptus.

Scialli AR, Bailey G, Beyer BK, Bøgh IB, Breslin WJ, Chen CL, DeLise AM, Hui JY, Moffat GJ, Stewart J, Thompson KE.

Reprod Toxicol. 2015 Dec;58:213-21. doi: 10.1016/j.reprotox.2015.10.015. Review.

PMID: 26545974

 

Pregnancy outcomes following exposure to abatacept during pregnancy.

Kumar M, Ray L, Vemuri S, Simon TA.

Semin Arthritis Rheum. 2015 Dec;45(3):351-6. doi: 10.1016/j.semarthrit.2015.06.016.

PMID: 26210783

 

Erratum to: Iron metabolism and iron supplementation in cancer patients.

Ludwig H, Evstatiev R, Kornek G, Aapro M, Bauernhofer T, Buxhofer-Ausch V, Fridrik M, Geissler D, Geissler K, Gisslinger H, Koller E, Kopetzky G, Lang A, Rumpold H, Steurer M, Kamali H, Link H.

Wien Klin Wochenschr. 2015 Dec;127(23-24):920-1. doi: 10.1007/s00508-015-0893-5. No abstract available.

PMID: 26613899

 

Iron metabolism and iron supplementation in cancer patients.

Ludwig H, Evstatiev R, Kornek G, Aapro M, Bauernhofer T, Buxhofer-Ausch V, Fridrik M, Geissler D, Geissler K, Gisslinger H, Koller E, Kopetzky G, Lang A, Rumpold H, Steurer M, Kamali H, Link H.

Wien Klin Wochenschr. 2015 Dec;127(23-24):907-19. doi: 10.1007/s00508-015-0842-3. Review. Erratum in: Wien Klin Wochenschr. 2015 Dec;127(23-24):920-1.

PMID: 26373748

 

Impact of moisture and magnesium stearate functionality on manufacturability of wet granulated metformin tablets.

Kestur U, Desai D, Sharif S, Wong B, Guo H, Tang D, Chan S.

Pharm Dev Technol. 2015 Nov 29:1-9. [Epub ahead of print]

PMID: 26616157

 

Triphenylethanamine Derivatives as Cholesteryl Ester Transfer Protein Inhibitors: Discovery of N-[(1R)-1-(3-Cyclopropoxy-4-fluorophenyl)-1-[3-fluoro-5-(1,1,2,2-tetrafluoroethoxy)phenyl]-2-phenylethyl]-4-fluoro-3-(trifluoromethyl)benzamide (BMS-795311).

Qiao JX, Wang TC, Adam LP, Chen AY, Taylor DS, Yang RZ, Zhuang S, Sleph PG, Li JP, Li D, Yin X, Chang M, Chen XQ, Shen H, Li J, Smith D, Wu DR, Leith L, Harikrishnan LS, Kamau MG, Miller MM, Bilder D, Rampulla R, Li YX, Xu C, Lawrence RM, Poss MA, Levesque P, Gordon DA, Huang CS, Finlay HJ, Wexler RR, Salvati ME.

J Med Chem. 2015 Nov 25;58(22):9010-26. doi: 10.1021/acs.jmedchem.5b01363.

PMID: 26524347

 

Polymorphisms near the IFNL3 Gene Associated with HCV RNA Spontaneous Clearance and Hepatocellular Carcinoma Risk.

Lee MH, Yang HI, Lu SN, Lin YJ, Jen CL, Wong KH, Chan SY, Chen LC, Wang LY, L'Italien G, Yuan Y, Chen CJ.

Sci Rep. 2015 Nov 25;5:17030. doi: 10.1038/srep17030.

PMID: 26602024

 

Impact of Genetic Mutations and Health Plan Access to Therapies on Treatment Response and Drug Costs Related to Tyrosine Kinase Inhibitor Treatment Among Patients With Chronic Myelogenous Leukemia.

Jabbour E, Makenbaeva D, Lingohr-Smith M, Lin J.

Am J Clin Oncol. 2015 Nov 17. [Epub ahead of print]

PMID: 26580245

 

Macrocyclic prolinyl acyl guanidines as inhibitors of β-secretase (BACE).

Boy KM, Guernon JM, Wu YJ, Zhang Y, Shi J, Zhai W, Zhu S, Gerritz SW, Toyn JH, Meredith JE, Barten DM, Burton CR, Albright CF, Good AC, Grace JE, Lentz KA, Olson RE, Macor JE, Thompson LA 3rd.

Bioorg Med Chem Lett. 2015 Nov 15;25(22):5040-7. doi: 10.1016/j.bmcl.2015.10.031.

PMID: 26497283

 

Applications of Fluorine in Medicinal Chemistry.

Gillis EP, Eastman KJ, Hill MD, Donnelly DJ, Meanwell NA.

J Med Chem. 2015 Nov 12;58(21):8315-59. doi: 10.1021/acs.jmedchem.5b00258. Review.

PMID: 26200936

 

Resensitizing daclatasvir-resistant hepatitis C variants by allosteric modulation of NS5A.

Sun JH, O'Boyle DR 2nd, Fridell RA, Langley DR, Wang C, Roberts SB, Nower P, Johnson BM, Moulin F, Nophsker MJ, Wang YK, Liu M, Rigat K, Tu Y, Hewawasam P, Kadow J, Meanwell NA, Cockett M, Lemm JA, Kramer M, Belema M, Gao M.

Nature. 2015 Nov 12;527(7577):245-8. doi: 10.1038/nature15711.

PMID: 26536115

 

Comparison of pharmaceutical formulations: ATR-FTIR spectroscopic imaging to study drug-carrier interactions.

Ewing AV, Biggart GD, Hale CR, Clarke GS, Kazarian SG.

Int J Pharm. 2015 Nov 10;495(1):112-21. doi: 10.1016/j.ijpharm.2015.08.068.

PMID: 26319636

 

Effect of milling temperatures on surface area, surface energy and cohesion of pharmaceutical powders.

Shah UV, Wang Z, Olusanmi D, Narang AS, Hussain MA, Tobyn MJ, Heng JY.

Int J Pharm. 2015 Nov 10;495(1):234-40. doi: 10.1016/j.ijpharm.2015.08.061.

PMID: 26315119

 

Drug usage analysis and health care resources consumption in naïve patients with rheumatoid arthritis.

Sangiorgi D, Benucci M, Nappi C, Perrone V, Buda S, Degli Esposti L.

Biologics. 2015 Nov 6;9:119-27. doi: 10.2147/BTT.S89286.

PMID: 26604680

 

Cost-effectiveness of dapagliflozin versus DPP-4 inhibitors as an add-on to Metformin in the Treatment of Type 2 Diabetes Mellitus from a UK Healthcare System Perspective.

Charokopou M, McEwan P, Lister S, Callan L, Bergenheim K, Tolley K, Postema R, Townsend R, Roudaut M.

BMC Health Serv Res. 2015 Nov 5;15:496. doi: 10.1186/s12913-015-1139-y.

PMID: 26541516

 

Inhibition of in vivo [(3)H]MK-801 binding by NMDA receptor open channel blockers and GluN2B antagonists in rats and mice.

Fernandes A, Wojcik T, Baireddy P, Pieschl R, Newton A, Tian Y, Hong Y, Bristow L, Li YW.

Eur J Pharmacol. 2015 Nov 5;766:1-8. doi: 10.1016/j.ejphar.2015.08.044.

PMID: 26325093

 

Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.

Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators..

N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665.

PMID: 26406148

 

Hepatic Disposition of Gemfibrozil and Its Major Metabolite Gemfibrozil 1-O-β-Glucuronide.

Kimoto E, Li R, Scialis RJ, Lai Y, Varma MV.

Mol Pharm. 2015 Nov 2;12(11):3943-52. doi: 10.1021/acs.molpharmaceut.5b00411.

PMID: 26378985

 

Development of a Generic Anti-PEG Antibody Assay Using BioScale's Acoustic Membrane MicroParticle Technology.

Dong H, Mora JR, Brockus C, Chilewski SD, Dodge R, Merrifield C, Dickerson WM, DeSilva B.

AAPS J. 2015 Nov;17(6):1511-6. doi: 10.1208/s12248-015-9799-4.

PMID: 26139446

 

Clinical features of pulmonary arterial hypertension in patients receiving dasatinib.

Shah NP, Wallis N, Farber HW, Mauro MJ, Wolf RA, Mattei D, Guha M, Rea D, Peacock A.

Am J Hematol. 2015 Nov;90(11):1060-4. doi: 10.1002/ajh.24174. Review.

PMID: 26284693

 

Long-term Survival with Ipilimumab: Experience from a National Expanded Access Program for Patients with Melanoma.

Krajsová I, Arenberger P, Lakomý R, Kubala E, Březinová I, Poprach A, Šťastný M, Mužík J, Melichar B.

Anticancer Res. 2015 Nov;35(11):6303-10.

PMID: 26504067

 

Application of Low- and Mid-Frequency Raman Spectroscopy to Characterize the Amorphous-Crystalline Transformation of Indomethacin.

Larkin PJ, Wasylyk J, Raglione M.

Appl Spectrosc. 2015 Nov;69(11):1217-28. doi: 10.1366/15-07926.

PMID: 26647045

 

Discrepancy between guidelines for stroke prevention in atrial fibrillation and practice patterns in primary care. The nationwide French AFIGP survey.

Sabouret P, Bricard M, Hermann MA, Cotté FE, Deret-Bixio L, Rushton-Smith S.

Arch Cardiovasc Dis. 2015 Nov;108(11):544-53. doi: 10.1016/j.acvd.2015.05.005.

PMID: 26113478

  

Using the Effects of Youngsters' Eyesight on Quality of Life Questionnaire to Measure Visual Outcomes in Children With Uveitis.

Angeles-Han ST, Yeh S, McCracken C, Jenkins K, Stryker D, Myoung E, Vogler LB, Rouster-Stevens K, Lambert SR, Harrison MJ, Prahalad S, Drews-Botsch C.

Arthritis Care Res (Hoboken). 2015 Nov;67(11):1513-20. doi: 10.1002/acr.22627.

PMID: 26037544

 

Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.

Corvari V, Narhi LO, Spitznagel TM, Afonina N, Cao S, Cash P, Cecchini I, DeFelippis MR, Garidel P, Herre A, Koulov AV, Lubiniecki T, Mahler HC, Mangiagalli P, Nesta D, Perez-Ramirez B, Polozova A, Rossi M, Schmidt R, Simler R, Singh S, Weiskopf A, Wuchner K.

Biologicals. 2015 Nov;43(6):457-73. doi: 10.1016/j.biologicals.2015.07.011. Review.

PMID: 26324466

 

Pseudosaccharin amines as potent and selective KV1.5 blockers.

Lloyd J, Finlay HJ, Kover A, Johnson J, Pi Z, Jiang J, Neels J, Cavallaro C, Wexler R, Conder ML, Shi H, Li D, Sun H, Chimalakonda A, Huang C, Salvati M, Levesque P.

Bioorg Med Chem Lett. 2015 Nov 1;25(21):4983-6. doi: 10.1016/j.bmcl.2015.02.066.

PMID: 25801931

 

Development of robust antibody purification by optimizing protein-A chromatography in combination with precipitation methodologies.

Chollangi S, Parker R, Singh N, Li Y, Borys M, Li Z.

Biotechnol Bioeng. 2015 Nov;112(11):2292-304. doi: 10.1002/bit.25639.

PMID: 25950654

 

Caprylic acid-induced impurity precipitation from protein A capture column elution pool to enable a two-chromatography-step process for monoclonal antibody purification.

Zheng J, Wang L, Twarowska B, Laino S, Sparks C, Smith T, Russell R, Wang M.

Biotechnol Prog. 2015 Nov-Dec;31(6):1515-25. doi: 10.1002/btpr.2154.

PMID: 26280674

 

Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma.

Yamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T.

Cancer Chemother Pharmacol. 2015 Nov;76(5):997-1004. doi: 10.1007/s00280-015-2873-x.

PMID: 26410424

 

Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma.

Yamazaki N, Uhara H, Fukushima S, Uchi H, Shibagaki N, Kiyohara Y, Tsutsumida A, Namikawa K, Okuyama R, Otsuka Y, Tokudome T.

Cancer Chemother Pharmacol. 2015 Nov;76(5):969-75. doi: 10.1007/s00280-015-2870-0.

PMID: 26407818

 

Cost-effectiveness of Apixaban Compared With Edoxaban for Stroke Prevention in Nonvalvular Atrial Fibrillation.

Lip GY, Lanitis T, Kongnakorn T, Phatak H, Chalkiadaki C, Liu X, Kuznik A, Lawrence J, Dorian P.

Clin Ther. 2015 Nov 1;37(11):2476-2488.e27. doi: 10.1016/j.clinthera.2015.09.005.

PMID: 26477648

 

Stroke associated with discontinuation of warfarin therapy for atrial fibrillation.

Spivey CA, Liu X, Qiao Y, Mardekian J, Parker RB, Phatak H, Masseria C, Kachroo S, Abdulsattar Y, Wang J.

Curr Med Res Opin. 2015 Nov;31(11):2021-9. doi: 10.1185/03007995.2015.1082995.

PMID: 26390258

 

Randomized, Double-Blind Trial of Triple Therapy With Saxagliptin Add-on to Dapagliflozin Plus Metformin in Patients With Type 2 Diabetes.

Matthaei S, Catrinoiu D, Celiński A, Ekholm E, Cook W, Hirshberg B, Chen H, Iqbal N, Hansen L.

Diabetes Care. 2015 Nov;38(11):2018-24. doi: 10.2337/dc15-0811.

PMID: 26324329

 

Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes.

Mathieu C, Ranetti AE, Li D, Ekholm E, Cook W, Hirshberg B, Chen H, Hansen L, Iqbal N.

Diabetes Care. 2015 Nov;38(11):2009-17. doi: 10.2337/dc15-0779.

PMID: 26246458

 

GPCR profiling: from hits to leads and from genotype to phenotype.

Cvijic ME, Sum CS, Alt A, Zhang L.

Drug Discov Today Technol. 2015 Nov;18:30-7. doi: 10.1016/j.ddtec.2015.10.005. Review.

PMID: 26723890

 

Rosuvastatin Liver Partitioning in Cynomolgus Monkeys: Measurement In Vivo and Prediction Using In Vitro Monkey Hepatocyte Uptake.

Morse BL, Cai H, MacGuire JG, Fox M, Zhang L, Zhang Y, Gu X, Shen H, Dierks EA, Su H, Luk CE, Marathe P, Shu YZ, Humphreys WG, Lai Y.

Drug Metab Dispos. 2015 Nov;43(11):1788-94. doi: 10.1124/dmd.115.065946.

PMID: 26341276

 

Pharmacology of smac mimetics; chemotype differentiation based on physical association with caspase regulators and cellular transport.

Talbott RL, Borzilleri RM, Chaudhry C, Fargnoli J, Shen H, Fairchild C, Barnhart B, Ortega M, McDonagh TE, Vuppugalla R, Vite GD, Hunt JT, Gottardis M, Naglich JG.

Exp Cell Res. 2015 Nov 1;338(2):251-60. doi: 10.1016/j.yexcr.2015.08.011.

PMID: 26302264

 

Hepatitis C virus drug resistance-associated substitutions: State of the art summary.

Lontok E, Harrington P, Howe A, Kieffer T, Lennerstrand J, Lenz O, McPhee F, Mo H, Parkin N, Pilot-Matias T, Miller V.

Hepatology. 2015 Nov;62(5):1623-32. doi: 10.1002/hep.27934. Review.

PMID: 26095927

 

Comparative efficacy and safety of daclatasvir/asunaprevir versus IFN-based regimens in genotype 1b hepatitis C virus infection.

Signorovitch JE, Betts KA, Song Y, Sorg RA, Li J, Behl AS, Kalsekar A.

J Comp Eff Res. 2015 Nov;4(6):593-605. doi: 10.2217/cer.15.33. Review.

PMID: 26159375

 

Peginterferon Lambda-1a Is Associated with a Low Incidence of Autoimmune Thyroid Disease in Chronic Hepatitis C.

Fredlund P, Hillson J, Gray T, Shemanski L, Dimitrova D, Srinivasan S.

J Interferon Cytokine Res. 2015 Nov;35(11):841-3. doi: 10.1089/jir.2014.0233.

PMID: 26376344

 

Scale Up of Pan Coating Process Using Quality by Design Principles.

Agrawal AM, Pandey P.

J Pharm Sci. 2015 Nov;104(11):3589-611. doi: 10.1002/jps.24582. Review.

PMID: 26202540

 

In vitro, antithrombotic and bleeding time studies of BMS-654457, a small-molecule, reversible and direct inhibitor of factor XIa.

Wong PC, Quan ML, Watson CA, Crain EJ, Harpel MR, Rendina AR, Luettgen JM, Wexler RR, Schumacher WA, Seiffert DA.

J Thromb Thrombolysis. 2015 Nov;40(4):416-23. doi: 10.1007/s11239-015-1258-7.

PMID: 26249722

 

The contribution of apixaban renal clearance to total clearance.

Frost C, Boyd RA.

J Thromb Thrombolysis. 2015 Nov;40(4):521-2. doi: 10.1007/s11239-015-1220-8. No abstract available.

PMID: 25962516

 

Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial.

Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM.

JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.

PMID: 26414022

 

Distinctive transcriptome alterations of prefrontal pyramidal neurons in schizophrenia and schizoaffective disorder.

Arion D, Corradi JP, Tang S, Datta D, Boothe F, He A, Cacace AM, Zaczek R, Albright CF, Tseng G, Lewis DA.

Mol Psychiatry. 2015 Nov;20(11):1397-405. doi: 10.1038/mp.2014.171.

PMID: 25560755

 

Long-term virologic outcomes following bariatric surgery in patients with HIV.

Zivich S, Cauterucci M, Allen S, Vetter M, Vinnard C.

Obes Res Clin Pract. 2015 Nov-Dec;9(6):633-5. doi: 10.1016/j.orcp.2015.09.002.

PMID: 26411387

 

Cost-Effectiveness of Apixaban Versus Other Noacs And Warfarin, During Hospitalization In The Private Brazilian Health System.

Tanaka S, Preto MC, Bernardino G, Nogueira F, Ferreira CN, Donato BM.

Value Health. 2015 Nov;18(7):A830. doi: 10.1016/j.jval.2015.09.312. No abstract available.

PMID: 26534432

 

Costo - Efectividad De Apixaban Con Otros Noacs (Dabigatran Y Rivaroxaban) En El Tratamiento De La Fibrilacion Auricular No Valvular (Fanv) En Pacientes De La Seguridad Social De Perú.

Sanabria C, Cabrejos J, Olortegui A, Guevara C, Garrido Lecca S.

Value Health. 2015 Nov;18(7):A829. doi: 10.1016/j.jval.2015.09.308. No abstract available.

PMID: 26534427

 

Cost-Effectiveness of Apixaban Versus Other New Oral Anticoagulants And Warfarin for Stroke Prevention In Atrial Fibrillation In Venezuela.

Fernández Ávila Y, Garcia KC, Garrido Lecca S, Donato BM, Juarez-Garcia A.

Value Health. 2015 Nov;18(7):A829. doi: 10.1016/j.jval.2015.09.309. No abstract available.

PMID: 26534424

 

The Relative Clinical and Economic Value of Ipilimumab in the Treatment of Metastatic Melanoma Versus Other Anti-Cancer Agents for Metastatic Diseases from a Brazilian Private Health Care System Perspective.

Stefani S, Tanaka S, Araujo R, Chagas K, Bernardino G, Donato BM.

Value Health. 2015 Nov;18(7):A819. doi: 10.1016/j.jval.2015.09.250. No abstract available.

PMID: 26534369

 

Apixaban In Patients With Atrial Fibrillation: Patient Characteristics Of The Latin America Cohort From A Multinational Clinical Trial.

Avezum A, Bahit MC, Hermosillo JA, Zanetti FL, Perafan P, Juarez-Garcia A, Vulcano C, Cubillos LA, Korenblat Donato BM.

Value Health. 2015 Nov;18(7):A809. doi: 10.1016/j.jval.2015.09.097. No abstract available.

PMID: 26534313

 

Simulated Treatment Comparison of Time-To-Event (And Other Non-Linear) Outcomes.

Ishak KJ, Rael M, Phatak H, Masseria C, Lanitis T.

Value Health. 2015 Nov;18(7):A719. doi: 10.1016/j.jval.2015.09.2723. No abstract available.

PMID: 26534029

 

A Comparison of Three Survival Models to Estimate The Cost-Effectiveness of Cancer Immunotherapy In The Treatment of Advanced Melanoma.

Bohensky M, Gorelik A, Kim H, Liew D.

Value Health. 2015 Nov;18(7):A699. doi: 10.1016/j.jval.2015.09.2613. No abstract available.

PMID: 26533919

 

Societal Burden And Impact On Health Related Quality Of Life (Hrqol) Of Non-Small Cell Lung Cancer (Nsclc) In Europe.

Enstone A, Panter C, Manley Daumont M, Miles R.

Value Health. 2015 Nov;18(7):A690. doi: 10.1016/j.jval.2015.09.2563. No abstract available.

PMID: 26533869

  

Economic Evaluation of Dasatynib In Treatment of Adult Patients With Philadelphia Chromosome Positive (Ph+) Acute Lymbphoblastic Leukemia (All) With Resistance or Intolerance to Prior Therapy In Poland.

Mucha J, Stelmachowski J, Walczak J, Pieniazek I, Obrzut G, Labak-Klimasara M.

Value Health. 2015 Nov;18(7):A671-2. doi: 10.1016/j.jval.2015.09.1975. No abstract available.

PMID: 26533764

 

Budget Impact Analysis of Dasatynib In Treatment of Adult Patients With Philadelphia Chromosome Positive (Ph+) Acute Lymbphoblastic Leukemia (All) With Resistance or Intolerance to Prior Therapy In Poland.

Mucha J, Stelmachowski J, Walczak J, Pieniazek I, Labak-Klimasara M, Obrzut G.

Value Health. 2015 Nov;18(7):A663. doi: 10.1016/j.jval.2015.09.2412. No abstract available.

PMID: 26533717

 

Cost-Effectiveness of Abatacept Compared to Adalimumab In Italy Based on A Head-To-Head Outcomes Study In Rheumatoid Arthritis.

Gaultney J, Nappi C, Benucci M, Iannazzo S, Sion K, Alemao E, Sabater J.

Value Health. 2015 Nov;18(7):A644. doi: 10.1016/j.jval.2015.09.2302. No abstract available.

PMID: 26533615

 

The Efficacy and Safety of Abatacept, Adalimumab, Etanercept And Tocilizumab are Comparable In Polyarticular Juvenile Idiopathic Arthritis.

Rathi H, Pennington B, Amadi A, Lister S, Nanuwa K.

Value Health. 2015 Nov;18(7):A636. doi: 10.1016/j.jval.2015.09.2258. No abstract available.

PMID: 26533567

 

Modeling The Cost-Effectiveness of The All Oral, Direct-Acting Antiviral Regimen Daclatasvir Plus Sofosbuvir In Patients Co-Infected With Hepatitis C Virus (Hcv) And Hiv.

McEwan P, Ward T, Webster S, Kalsekar A, Brenner M, Yuan Y.

Value Health. 2015 Nov;18(7):A628. doi: 10.1016/j.jval.2015.09.2213. No abstract available.

PMID: 26533528

 

Association between Weight Change, Diabetes-Related Healthcare Costs, and HbA1c among Patients with Type 2 Diabetes.

Mukherjee J, Sternhufvud C, Smith N, Bell K, Stott-Miller M, Johnston S.

Value Health. 2015 Nov;18(7):A605-6. doi: 10.1016/j.jval.2015.09.2088. No abstract available.

PMID: 26533397

 

Cost of Achieving Combined Improvements in HbA1c and Weight without Hypoglycaemia over 4 Years in a Post-Hoc Analysis of Dapagliflozin + MET Vs Glipizide + MET.

Johansen P, Mukherjee J, Sörstadius E, Sternhufvud C.

Value Health. 2015 Nov;18(7):A604-5. doi: 10.1016/j.jval.2015.09.2083. No abstract available.

PMID: 26533390

 

Cost Effectiveness Analysis of The Use of Daclatasvir for the Treatment of Hepatitis C Virus (Hcv) Genotypes 3 in Cirrhotic Patients Within the Italian National Health Service.

Restelli U, Bonfanti M, Alberti A, Lazzarin A, Nappi C, Croce D.

Value Health. 2015 Nov;18(7):A587. doi: 10.1016/j.jval.2015.09.1498. No abstract available.

PMID: 26533297

 

Direct Medical Cost Associated With The Diagnosis and Treatment of Patients With Chronic Hepatitis-B In Three Large Metropolitan Cities In India - A Pilot Study.

Marfatia S, Gupta K, Mukherjee A, Mattoo V.

Value Health. 2015 Nov;18(7):A581-2. doi: 10.1016/j.jval.2015.09.1945. No abstract available.

PMID: 26533268

 

Budget Impact Analysis of The Use of Daclatasvir for The Treatment of Hepatitis C Virus (Hcv) Genotypes 3, In The Italian Setting.

Restelli U, Bonfanti M, Alberti A, Lazzarin A, Nappi C, Croce D.

Value Health. 2015 Nov;18(7):A580. doi: 10.1016/j.jval.2015.09.1935. No abstract available.

PMID: 26533258

 

Epidemiology of Hepatitis C Patients In Italian Local Health Units (Lhus).

Degli Esposti L, Sangiorgi D, Buda S, Crovato E, Nappi C, Lefevre C.

Value Health. 2015 Nov;18(7):A579. doi: 10.1016/j.jval.2015.09.1928. No abstract available.

PMID: 26533255

 

Daclatasvir +Asunaprevir Versus Sofosbuvir/Ledipasvir for The Treatment of Chronic Hepatitis C Genotype 1 In Japanese Patients: A Matching-Adjusted Indirect Comparison.

Swallow E, Kelley C, Ristovska L, Signorovitch JE, Kalsekar A, Wygant G, McPhee F.

Value Health. 2015 Nov;18(7):A576. doi: 10.1016/j.jval.2015.09.1915. No abstract available.

PMID: 26533237

 

Clinical And Health-Economic Criteria for the Assessment of New Immune-Oncologic Drugs in Spain.

López-Bastida J, Oliva Moreno J, Sánchez Martínez F, González García P.

Value Health. 2015 Nov;18(7):A485. doi: 10.1016/j.jval.2015.09.1329. No abstract available.

PMID: 26532723

 

Patient Count Forecasts of Advanced Non-Small Cell Lung Cancer: Results from the UK, Germany, France, Italy and Spain (Eu-5).

Kish JK, O'Day K, Manley-Daumont M, Campbell DJ, Penrod J.

Value Health. 2015 Nov;18(7):A484. doi: 10.1016/j.jval.2015.09.1324. No abstract available.

PMID: 26532716

 

Progressive Disease Does Not Impact Hrqol In Patients Receiving Nivolumab For The Treatment Of Unresectable Or Metastatic Melanoma.

Harrison JP, Kim H.

Value Health. 2015 Nov;18(7):A475. doi: 10.1016/j.jval.2015.09.1271. No abstract available.

PMID: 26532667

 

Eastern Cooperative Oncology Group (Ecog) Performance Status (Ps) Is An Independent Predictor Of Hrqol In Unresectable Or Metastatic Melanoma.

Harrison JP, Kim H.

Value Health. 2015 Nov;18(7):A474. doi: 10.1016/j.jval.2015.09.1267. No abstract available.

PMID: 26532662

 

Predictors Of Utility Over Time Among Patients With Treatment-Naïve Advanced Melanoma From The Phase 3 Checkmate 066 Trial.

Paly V, Colby C, Gilloteau I, Exuzides A, Briggs A.

Value Health. 2015 Nov;18(7):A474. doi: 10.1016/j.jval.2015.09.1265. No abstract available.

PMID: 26532660

 

Understanding The Impact Of Patient And Physician Preferences In Personalized Treatment For Melanoma Using A Discrete Choice Experiment.

Stenehjem D, Korytowsky B, Oderda G, Wanishayakorn T, Bauer H, Brixner D.

Value Health. 2015 Nov;18(7):A469-70. doi: 10.1016/j.jval.2015.09.1241. No abstract available.

PMID: 26532636

 

Mapping Health State Utility Values From Eortc Data Collected From A Clinical Trial Population With Relapsed/Refractory Multiple Myeloma.

Quinn C, Hirji I, Shingler SL, Davis C.

Value Health. 2015 Nov;18(7):A468. doi: 10.1016/j.jval.2015.09.1233. No abstract available.

PMID: 26532629

 

Treatment Sequencing Patterns And Costs of Care in Patients with Relapsed/Refractory Multiple Myeloma.

Potluri R, Farr AM, Hirji I, Davis C, Bhandari H, Oukessou A.

Value Health. 2015 Nov;18(7):A450. doi: 10.1016/j.jval.2015.09.1134. No abstract available.

PMID: 26532531

 

Resource Utilization Among Advanced Squamous and non-Squamous non-Small Cell Lung Cancer Patients Receiving Second-Line Treatment in France, Germany, Italy, and Spain: Results of A Retrospective Medical Chart Review.

Solem CT, Penrod JR, Lees M, Manley Daumont M, Macahilig CP, Baeten S, Verleger K, Wilke T.

Value Health. 2015 Nov;18(7):A450. doi: 10.1016/j.jval.2015.09.1133. No abstract available.

PMID: 26532530

 

An Assessment of The Hospitalization Costs of Melanoma in France in the Advanced/Metastatic Setting: the Melissa Study (Melanoma in Hospital Costs Assessment).

de Léotoing L, Combemale P, Fernandes J, Bregman B, Amaz C, Vainchtock A, Gaudin A.

Value Health. 2015 Nov;18(7):A447. doi: 10.1016/j.jval.2015.09.1115. No abstract available.

PMID: 26532513

 

The Relative Efficacy And Safety Of Treatments In Second-Line Management Of Chronic Myeloid Leukaemia: Systematic Review And Network Meta-Analysis Feasibility Study.

Kroes MA, Witkowski MA, Paine A, Zagorska A, Almeida AM.

Value Health. 2015 Nov;18(7):A435. doi: 10.1016/j.jval.2015.09.1047. No abstract available.

PMID: 26532449

 

Overall Survival (Os) And Quality-Of-Life (Qol) Outcomes In Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck (Scchn): A Systematic Literature Review.

Signorovitch J, Li N, Zhong Y, Shaw J, Dastani H, Orsini L.

Value Health. 2015 Nov;18(7):A433-4. doi: 10.1016/j.jval.2015.09.1040. No abstract available.

PMID: 26532439

 

Overall Survival (Os), Quality Of Life (Qol), And Neurocognitive Function (Nf) In Recurrent Glioblastoma Multiforme (Gbm): A Systematic Literature Review.

Signorovitch J, Li N, Ohashi E, Dastani H, Shaw J, Orsini L.

Value Health. 2015 Nov;18(7):A433. doi: 10.1016/j.jval.2015.09.1036. No abstract available.

PMID: 26532436

 

Persistence To Vitamin-K Antagonists (Vka) And Novel Oral Anticoagulants (Noacs) In Non-Valvular Atrial Fibrillation (Nvaf): An Observational Study Using A Comprehensive Regional Database In Catalonia, Spain.

Lefevre C, Benhaddi H, Lacoin L, Diaz Cuervo H, Lee Y, Evans D, Budd D.

Value Health. 2015 Nov;18(7):A403. doi: 10.1016/j.jval.2015.09.938. No abstract available.

PMID: 26532274

 

Factors Associated With The Duration Of Anticoagulation Therapy Following Acute Vte In England In General Practice: An Observational Study Using Cprd-Hes Databases.

Lacoin L, Ridha E, Lefevre C, Moorthy V, Vasudev M, Lister S, Bird A, Minns I, Evans D, Alikhan R, Bakhai A.

Value Health. 2015 Nov;18(7):A401. doi: 10.1016/j.jval.2015.09.927. No abstract available.

PMID: 26532263

 

Resource Utilisation And Bleeding Events During Anticoagulation Treatment: Real-World Findings From England.

Lister S, Lefevre C, Menown I, Alikhan R, Lacoin L, Bird A, You M, Ridha E, Evans D.

Value Health. 2015 Nov;18(7):A396-7. doi: 10.1016/j.jval.2015.09.899. No abstract available.

PMID: 26532233

 

Cost-Utility Analysis Of Apixaban In The Acute Treatment And Prevention Of Venous Thromboembolism In France.

Stern S, Cotte F, Minacori R, Gosden T, Hamilton M, Phatak H, Quon P.

Value Health. 2015 Nov;18(7):A395. doi: 10.1016/j.jval.2015.09.892. No abstract available.

PMID: 26532232

 

Local Cost Study Of Treatment Of Venous Thromboembolism In Turkey.

Tatar M, Senturk A, Tuna E, Bilginer B, Ulus AT, Buyuktuna N, Hacibedel B, Saribas G.

Value Health. 2015 Nov;18(7):A388-9. doi: 10.1016/j.jval.2015.09.856. No abstract available.

PMID: 26532194

 

Resource Utilization And Treatment Costs Of Stroke In Patients With Non-Valvular Atrial Fibrillation In Spain.

Lefevre C, Benhaddi H, Lacoin L, Diaz Cuervo H, Lee Y, Evans D, Budd D.

Value Health. 2015 Nov;18(7):A388. doi: 10.1016/j.jval.2015.09.852. No abstract available.

PMID: 26532190

 

Medical Cost Of Patients With Non-Valvular Atrial Fibrillation (Nvaf) And Treated With Vitamin K Antagonists (Vkas) According To Inr Control Status In Spain.

Postema R, Bardoulat I, Roset M, Maurel F, Lefevre C, Evans D.

Value Health. 2015 Nov;18(7):A385. doi: 10.1016/j.jval.2015.09.836. No abstract available.

PMID: 26532176

 

Patient Profile of New Users of Novel Oral Anticoagulants in non-Valvular Atrial Fibrillation (Nvaf): Real-World Evidence from Primary Care Data in Germany.

Lefevre C, Johnson M, Maguire A, Collings S, Kloss S, Evans D.

Value Health. 2015 Nov;18(7):A375. doi: 10.1016/j.jval.2015.09.776. No abstract available.

PMID: 26532119

 

Access to Innovative Drugs in Patients with Metastatic Lung Cancer in French Public Hospitals (the Territoire Study).

Scherpereel A, Fernandes J, Cotté F, Blein C, Debieuvre D, Durand-Zaleski I, Gaudin A, Ozan N, Saitta B, Souquet P, Vainchtock A, Westeel V, Chouaïd C.

Value Health. 2015 Nov;18(7):A341. doi: 10.1016/j.jval.2015.09.145. No abstract available.

PMID: 26531933

 

A Cost Effectiveness Analysis of Nivolumab Compared to Ipilimumab for the Treatment of Braf Wild-Type Advanced Melanoma in Australia.

Bohensky M, Pasupathi K, Gorelik A, Kim H, Harrison JP, Liew D.

Value Health. 2015 Nov;18(7):A340. doi: 10.1016/j.jval.2015.09.138. No abstract available.

PMID: 26531928

 

Partitioned Survival Versus State Transition Modeling in Oncology: a Case Study with Nivolumab in Advanced Melanoma.

Briggs A, Baker TM, Gilloteau I, Orsini L, Wagner S, Paly V.

Value Health. 2015 Nov;18(7):A338. doi: 10.1016/j.jval.2015.09.130. No abstract available.

PMID: 26531916

 

Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.

Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR.

N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643.

PMID: 26412456

 

Mono-Oxidation of Bidentate Bis-phosphines in Catalyst Activation: Kinetic and Mechanistic Studies of a Pd/Xantphos-Catalyzed C-H Functionalization.

Ji Y, Plata RE, Regens CS, Hay M, Schmidt M, Razler T, Qiu Y, Geng P, Hsiao Y, Rosner T, Eastgate MD, Blackmond DG.

J Am Chem Soc. 2015 Oct 21;137(41):13272-81. doi: 10.1021/jacs.5b01913.

PMID: 26461028

 

Syn-Selective Synthesis of β-Branched α-Amino Acids by Alkylation of Glycine-Derived Imines with Secondary Sulfonates.

Lou S, McKenna GM, Tymonko SA, Ramirez A, Benkovics T, Conlon DA, González-Bobes F.

Org Lett. 2015 Oct 16;17(20):5000-3. doi: 10.1021/acs.orglett.5b02448.

PMID: 26444227

 

The application of high-resolution mass spectrometry-based data-mining tools in tandem to metabolite profiling of a triple drug combination in humans.

Xing J, Zang M, Zhang H, Zhu M.

Anal Chim Acta. 2015 Oct 15;897:34-44. doi: 10.1016/j.aca.2015.09.034.

PMID: 26515003

 

Non-basic azolotriazinone MCHR1 antagonists for the treatment of obesity: An empirical brain-exposures-driven candidate selection for in vivo efficacy studies.

Devasthale P, Wang W, Mignone J, Renduchintala K, Radhakrishnan S, Dhanapal J, Selvaraj J, Kuppusamy R, Pelleymounter MA, Longhi D, Huang N, Flynn N, Azzara AV, Rohrbach K, Devenny J, Rooney S, Thomas M, Glick S, Godonis H, Harvey S, Cullen MJ, Zhang H, Caporuscio C, Stetsko P, Grubb M, Huang C, Zhang L, Freeden C, Murphy BJ, Robl JA, Washburn WN.

Bioorg Med Chem Lett. 2015 Oct 15;25(20):4412-8. doi: 10.1016/j.bmcl.2015.09.018.

PMID: 26386604

 

Discovery of ((4-(5-(Cyclopropylcarbamoyl)-2-methylphenylamino)-5-methylpyrrolo[1,2-f][1,2,4]triazine-6-carbonyl)(propyl)carbamoyloxy)methyl-2-(4-(phosphonooxy)phenyl)acetate (BMS-751324), a Clinical Prodrug of p38α MAP Kinase Inhibitor.

Liu C, Lin J, Hynes J, Wu H, Wrobleski ST, Lin S, Dhar TG, Vrudhula VM, Sun JH, Chao S, Zhao R, Wang B, Chen BC, Everlof G, Gesenberg C, Zhang H, Marathe PH, McIntyre KW, Taylor TL, Gillooly K, Shuster DJ, McKinnon M, Dodd JH, Barrish JC, Schieven GL, Leftheris K.

J Med Chem. 2015 Oct 8;58(19):7775-84. doi: 10.1021/acs.jmedchem.5b00839.

PMID: 26359680

 

The structure of the death receptor 4-TNF-related apoptosis-inducing ligand (DR4-TRAIL) complex.

Ramamurthy V, Yamniuk AP, Lawrence EJ, Yong W, Schneeweis LA, Cheng L, Murdock M, Corbett MJ, Doyle ML, Sheriff S.

Acta Crystallogr F Struct Biol Commun. 2015 Oct;71(Pt 10):1273-81. doi: 10.1107/S2053230X15016416.

PMID: 26457518

 

Effect of an intensive lifestyle intervention on atrial fibrillation risk in individuals with type 2 diabetes: the Look AHEAD randomized trial.

Alonso A, Bahnson JL, Gaussoin SA, Bertoni AG, Johnson KC, Lewis CE, Vetter M, Mantzoros CS, Jeffery RW, Soliman EZ; Look AHEAD Research Group..

Am Heart J. 2015 Oct;170(4):770-777.e5. doi: 10.1016/j.ahj.2015.07.026.

PMID: 26386801

 

The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study.

Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P.

Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

PMID: 26138593

 

Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.

Lovell DJ, Ruperto N, Mouy R, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Huppertz HI, Job Deslandre C, Minden K, Punaro M, Block AJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation..

Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

PMID: 26097215

 

[Cost-effectiveness analysis of dapagliflozin compared to DPP4 inhibitors and other oral antidiabetic drugs in the treatment of type-2 diabetes mellitus in Spain].

Abad Paniagua EJ, Casado Escribano P, Fernández Rodriguez JM, Morales Escobar FJ, Betegón Nicolás L, Sánchez-Covisa J, Brosa M.

Aten Primaria. 2015 Oct;47(8):505-13. doi: 10.1016/j.aprim.2014.11.002. Spanish.

PMID: 25555492

 

Beyond classical derivatization: analyte 'derivatives' in the bioanalysis of endogenous and exogenous compounds.

Barnaby OS, Benitex Y, Cantone JL, McNaney CA, Olah TV, Drexler DM.

Bioanalysis. 2015 Oct;7(19):2501-13. doi: 10.4155/bio.15.171.

PMID: 26466806

 

Design and synthesis of carbazole carboxamides as promising inhibitors of Bruton's tyrosine kinase (BTK) and Janus kinase 2 (JAK2).

Liu Q, Batt DG, Lippy JS, Surti N, Tebben AJ, Muckelbauer JK, Chen L, An Y, Chang C, Pokross M, Yang Z, Wang H, Burke JR, Carter PH, Tino JA.

Bioorg Med Chem Lett. 2015 Oct 1;25(19):4265-9. doi: 10.1016/j.bmcl.2015.07.102.

PMID: 26320619

 

The Effectiveness of Tyrosine Kinase Inhibitors and Molecular Monitoring Patterns in Newly Diagnosed Patients With Chronic Myeloid Leukemia in the Community Setting.

Di Bella NJ, Bhowmik D, Bhor M, Yap M, Middlebrook B, Rembert D, Cain Z, Okoro T, Bolinder B, Patt D, Jabbour EJ.

Clin Lymphoma Myeloma Leuk. 2015 Oct;15(10):599-605. doi: 10.1016/j.clml.2015.06.006.

PMID: 26208445

 

Utility of Ion Mobility Mass Spectrometry for Drug-to-Antibody Ratio Measurements in Antibody-Drug Conjugates.

Huang RY, Deyanova EG, Passmore D, Rangan V, Deshpande S, Tymiak AA, Chen G.

J Am Soc Mass Spectrom. 2015 Oct;26(10):1791-4. doi: 10.1007/s13361-015-1203-1.

PMID: 26122520

 

Dried blood spot analysis without dilution: Application to the LC-MS/MS determination of BMS-986001 in rat dried blood spot.

Yuan L, Schuster A, Shen JX, Garrison-Borowski P, Aubry AF.

J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:201-9. doi: 10.1016/j.jchromb.2015.08.029.

PMID: 26340763

 

Quantitative bioanalysis of antibody-conjugated payload in monkey plasma using a hybrid immuno-capture LC-MS/MS approach: Assay development, validation, and a case study.

Liu A, Kozhich A, Passmore D, Gu H, Wong R, Zambito F, Rangan VS, Myler H, Aubry AF, Arnold ME, Wang J.

J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:54-62. doi: 10.1016/j.jchromb.2015.08.007.

PMID: 26310897

 

Comparison of different QT interval correction methods for heart rate and QT beat-to-beat method in a thorough QT study of triple monoamine reuptake inhibitor BMS-820836.

Zheng M, Burt D, Chan W, Hawthorne D, Gasior M, Bhagwagar Z, Keswani S, AbuTarif M, Bertz R.

J Clin Pharmacol. 2015 Oct;55(10):1137-46. doi: 10.1002/jcph.528.

PMID: 25904041

 

Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial.

Lalezari JP, Latiff GH, Brinson C, Echevarría J, Treviño-Pérez S, Bogner JR, Thompson M, Fourie J, Sussmann Pena OA, Mendo Urbina FC, Martins M, Diaconescu IG, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team..

Lancet HIV. 2015 Oct;2(10):e427-37. doi: 10.1016/S2352-3018(15)00177-0.

PMID: 26423650

 

Sensitivity of Small Cell Lung Cancer to BET Inhibition Is Mediated by Regulation of ASCL1 Gene Expression.

Lenhart R, Kirov S, Desilva H, Cao J, Lei M, Johnston K, Peterson R, Schweizer L, Purandare A, Ross-Macdonald P, Fairchild C, Wong T, Wee S.

Mol Cancer Ther. 2015 Oct;14(10):2167-74. doi: 10.1158/1535-7163.MCT-15-0037.

PMID: 26253517

 

Establishing best practise in the application of expert review of mutagenicity under ICH M7.

Barber C, Amberg A, Custer L, Dobo KL, Glowienke S, Van Gompel J, Gutsell S, Harvey J, Honma M, Kenyon MO, Kruhlak N, Muster W, Stavitskaya L, Teasdale A, Vessey J, Wichard J.

Regul Toxicol Pharmacol. 2015 Oct;73(1):367-77. doi: 10.1016/j.yrtph.2015.07.018.

PMID: 26248005

 

Comparison of physiologic and pharmacologic parameters in Asian and mauritius cynomolgus macaques.

Kozlosky JC, Mysore J, Clark SP, Burr HN, Li J, Aranibar N, Vuppugalla R, West RC, Mangipudy RS, Graziano MJ.

Regul Toxicol Pharmacol. 2015 Oct;73(1):27-42. doi: 10.1016/j.yrtph.2015.06.008.

PMID: 26111605

 

PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development.

Ivens IA, Achanzar W, Baumann A, Brändli-Baiocco A, Cavagnaro J, Dempster M, Depelchin BO, Rovira AR, Dill-Morton L, Lane JH, Reipert BM, Salcedo T, Schweighardt B, Tsuruda LS, Turecek PL, Sims J.

Toxicol Pathol. 2015 Oct;43(7):959-83. doi: 10.1177/0192623315591171. Review.

PMID: 26239651

 

Investigation into process-induced de-aggregation of cohesive micronised API particles.

Hoffmann M, Wray PS, Gamble JF, Tobyn M.

Int J Pharm. 2015 Sep 30;493(1-2):341-6. doi: 10.1016/j.ijpharm.2015.07.073.

PMID: 26235919

 

The use of in situ near infrared imaging and Raman mapping to study the disproportionation of a drug HCl salt during dissolution.

Wray PS, Sinclair WE, Jones JW, Clarke GS, Both D.

Int J Pharm. 2015 Sep 30;493(1-2):198-207. doi: 10.1016/j.ijpharm.2015.07.045.

PMID: 26200745

 

Ligand-Based Discovery of a New Scaffold for Allosteric Modulation of the μ-Opioid Receptor.

Bisignano P, Burford NT, Shang Y, Marlow B, Livingston KE, Fenton AM, Rockwell K, Budenholzer L, Traynor JR, Gerritz SW, Alt A, Filizola M.

J Chem Inf Model. 2015 Sep 28;55(9):1836-43. doi: 10.1021/acs.jcim.5b00388.

PMID: 26347990

 

Cost-Effectiveness of Cetuximab as First-line Treatment for Metastatic Colorectal Cancer in the United States.

Shankaran V, Ortendahl JD, Purdum AG, Bolinder B, Anene AM, Sun GH, Bentley TG.

Am J Clin Oncol. 2015 Sep 22. [Epub ahead of print]

PMID: 26398184

 

FcγRs Modulate the Anti-tumor Activity of Antibodies Targeting the PD-1/PD-L1 Axis.

Dahan R, Sega E, Engelhardt J, Selby M, Korman AJ, Ravetch JV.

Cancer Cell. 2015 Sep 14;28(3):285-95. doi: 10.1016/j.ccell.2015.08.004. Erratum in: Cancer Cell. 2015 Oct 12;28(4):543.

PMID: 26373277

 

Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study.

Simó R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzmàn J, Dotta F, Festa A, Zhou M, Kiljański J.

Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.

PMID: 26338040

 

Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples.

Fung EN, Aubry AF, Allentoff A, Ji QC.

AAPS J. 2015 Sep;17(5):1168-76. doi: 10.1208/s12248-015-9783-z.

PMID: 25975617

 

Identifying amyloid pathology-related cerebrospinal fluid biomarkers for Alzheimer's disease in a multicohort study.

Leung YY, Toledo JB, Nefedov A, Polikar R, Raghavan N, Xie SX, Farnum M, Schultz T, Baek Y, Deerlin VV, Hu WT, Holtzman DM, Fagan AM, Perrin RJ, Grossman M, Soares HD, Kling MA, Mailman M, Arnold SE, Narayan VA, Lee VM, Shaw LM, Baker D, Wittenberg GM, Trojanowski JQ, Wang LS.

Alzheimers Dement (Amst). 2015 Sep 1;1(3):339-348.

PMID: 26693175

 

Assessment of drug-drug interactions between daclatasvir and methadone or buprenorphine-naloxone.

Garimella T, Wang R, Luo WL, Wastall P, Kandoussi H, DeMicco M, Bruce RD, Hwang C, Bertz R, Bifano M.

Antimicrob Agents Chemother. 2015 Sep;59(9):5503-10. doi: 10.1128/AAC.00478-15.

PMID: 26124175

 

Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer.

Phillips T, Simmons P, Inzunza HD, Cogswell J, Novotny J Jr, Taylor C, Zhang X.

Appl Immunohistochem Mol Morphol. 2015 Sep;23(8):541-9. doi: 10.1097/PAI.0000000000000256.

PMID: 26317305

 

Bioanalysis of acetylcarnitine in cerebrospinal fluid by HILIC-mass spectrometry.

Holder BR, McNaney CA, Luchetti D, Schaeffer E, Drexler DM.

Biomed Chromatogr. 2015 Sep;29(9):1375-9. doi: 10.1002/bmc.3433.

PMID: 25712252

 

Systematic interpolation method predicts protein chromatographic elution from batch isotherm data without a detailed mechanistic isotherm model.

Creasy A, Barker G, Yao Y, Carta G.

Biotechnol J. 2015 Sep;10(9):1400-11. doi: 10.1002/biot.201500089.

PMID: 26015091

 

Adaptation to high throughput batch chromatography enhances multivariate screening.

Barker GA, Calzada J, Herzer S, Rieble S.

Biotechnol J. 2015 Sep;10(9):1493-8. doi: 10.1002/biot.201400671.

PMID: 25914370

 

Efficient high-throughput biological process characterization: Definitive screening design with the ambr250 bioreactor system.

Tai M, Ly A, Leung I, Nayar G.

Biotechnol Prog. 2015 Sep-Oct;31(5):1388-95. doi: 10.1002/btpr.2142.

PMID: 26138048

 

The pharmacokinetics of peginterferon lambda-1a following single dose administration to subjects with impaired renal function.

Hruska MW, Adamczyk R, Colston E, Hesney M, Stonier M, Myler H, Bertz R.

Br J Clin Pharmacol. 2015 Sep;80(3):515-24. doi: 10.1111/bcp.12634.

PMID: 25807956

 

Nivolumab and Urelumab Enhance Antitumor Activity of Human T Lymphocytes Engrafted in Rag2-/-IL2Rγnull Immunodeficient Mice.

Sanmamed MF, Rodriguez I, Schalper KA, Oñate C, Azpilikueta A, Rodriguez-Ruiz ME, Morales-Kastresana A, Labiano S, Pérez-Gracia JL, Martín-Algarra S, Alfaro C, Mazzolini G, Sarno F, Hidalgo M, Korman AJ, Jure-Kunkel M, Melero I.

Cancer Res. 2015 Sep 1;75(17):3466-78. doi: 10.1158/0008-5472.CAN-14-3510.

PMID: 26113085

 

Dapagliflozin lowers blood pressure in hypertensive and non-hypertensive patients with type 2 diabetes.

Sjöström CD, Johansson P, Ptaszynska A, List J, Johnsson E.

Diab Vasc Dis Res. 2015 Sep;12(5):352-8. doi: 10.1177/1479164115585298.

PMID: 26008804

 

Assessing Bladder Cancer Risk in Type 2 Diabetes Clinical Trials: the Dapagliflozin Drug Development Program as a 'Case Study'.

Ptaszynska A, Cohen SM, Messing EM, Reilly TP, Johnsson E, Johnsson K.

Diabetes Ther. 2015 Sep;6(3):357-75. doi: 10.1007/s13300-015-0128-9.

PMID: 26323372

 

Integrated risk assessment of suicidal ideation and behavior in drug development.

Muller PY, Dambach D, Gemzik B, Hartmann A, Ratcliffe S, Trendelenburg C, Urban L.

Drug Discov Today. 2015 Sep;20(9):1135-42. doi: 10.1016/j.drudis.2015.05.010. Review.

PMID: 26022402

 

Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome.

Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators..

Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346.

PMID: 26109589

 

Challenges and solutions in the bioanalysis of BMS-986094 and its metabolites including a highly polar, active nucleoside triphosphate in plasma and tissues using LC-MS/MS.

Liu A, Lute J, Gu H, Wang B, Trouba KJ, Arnold ME, Aubry AF, Wang J.

J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Sep 1;1000:29-40. doi: 10.1016/j.jchromb.2015.07.006.

PMID: 26209768

 

Synthesis of 2-(14)C-iminothiolane and 2-(13)C,(15)N-iminothiolane (Traut's reagent).

Wallace M, Allentoff AJ, Brailsford J, Gong S, Bonacorsi S Jr, Rinaldi F.

J Labelled Comp Radiopharm. 2015 Sep-Oct;58(11-12):429-32. doi: 10.1002/jlcr.3345.

PMID: 26365707

 

Gordon L. Amidon: Very Sustained Drug Absorption.

Donovan MD, Polli JE, Langguth P, Tamai I, Vig B, Yu LX.

J Pharm Sci. 2015 Sep;104(9):2650-63. doi: 10.1002/jps.24523. No abstract available.

PMID: 26053319

 

Preclinical Pharmacokinetics and In Vitro Metabolism of Asunaprevir (BMS-650032), a Potent Hepatitis C Virus NS3 Protease Inhibitor.

Mosure KW, Knipe JO, Browning M, Arora V, Shu YZ, Phillip T, Mcphee F, Scola P, Balakrishnan A, Soars MG, Santone K, Sinz M.

J Pharm Sci. 2015 Sep;104(9):2813-23. doi: 10.1002/jps.24356.

PMID: 25631585

 

Discovery of D1 Dopamine Receptor Positive Allosteric Modulators: Characterization of Pharmacology and Identification of Residues that Regulate Species Selectivity.

Lewis MA, Hunihan L, Watson J, Gentles RG, Hu S, Huang Y, Bronson J, Macor JE, Beno BR, Ferrante M, Hendricson A, Knox RJ, Molski TF, Kong Y, Cvijic ME, Rockwell KL, Weed MR, Cacace AM, Westphal RS, Alt A, Brown JM.

J Pharmacol Exp Ther. 2015 Sep;354(3):340-9. doi: 10.1124/jpet.115.224071.

PMID: 26109678

 

Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

Benjamin A, Gallacher DJ, Greiter-Wilke A, Guillon JM, Kasai C, Ledieu D, Levesque P, Prelle K, Ratcliffe S, Sannajust F, Valentin JP.

J Pharmacol Toxicol Methods. 2015 Sep-Oct;75:101-10. doi: 10.1016/j.vascn.2015.01.004.

PMID: 25637943

 

BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase.

Hughes TP, Saglio G, Quintás-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A.

Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168.

PMID: 26118315

 

Global patterns of hepatocellular carcinoma management from diagnosis to death: the BRIDGE Study.

Park JW, Chen M, Colombo M, Roberts LR, Schwartz M, Chen PJ, Kudo M, Johnson P, Wagner S, Orsini LS, Sherman M.

Liver Int. 2015 Sep;35(9):2155-66. doi: 10.1111/liv.12818.

PMID: 25752327

 

Use of demographic and pharmacy data to identify patients included within both the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN).

Carbonari DM, Saine ME, Newcomb CW, Blak B, Roy JA, Haynes K, Wood J, Gallagher AM, Bhullar H, Cardillo S, Hennessy S, Strom BL, Lo Re V 3rd.

Pharmacoepidemiol Drug Saf. 2015 Sep;24(9):999-1003. doi: 10.1002/pds.3844.

PMID: 26213344

 

Prediction of pH dependent absorption using in vitro, in silico, and in vivo rat models: Early liability assessment during lead optimization.

Saxena A, Shah D, Padmanabhan S, Gautam SS, Chowan GS, Mandlekar S, Desikan S.

Eur J Pharm Sci. 2015 Aug 30;76:173-80. doi: 10.1016/j.ejps.2015.05.006.

PMID: 25960252

 

Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH.

Circulation. 2015 Aug 25;132(8):624-32. doi: 10.1161/CIRCULATIONAHA.114.014807.

PMID: 26106009

 

Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.

Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators..

N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153.

PMID: 26196502

 

Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial.

Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FW, De Caterina R, Ogawa H, Wallentin L, Alexander JH.

J Am Coll Cardiol. 2015 Aug 18;66(7):777-87. doi: 10.1016/j.jacc.2015.06.027.

PMID: 26271059

 

Incidence of malignancy in adult patients with rheumatoid arthritis: a meta-analysis.

Simon TA, Thompson A, Gandhi KK, Hochberg MC, Suissa S.

Arthritis Res Ther. 2015 Aug 15;17:212. doi: 10.1186/s13075-015-0728-9. Review. Erratum in: Arthritis Res Ther. 2016;18(1):100.

PMID: 26271620

 

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators..

N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654.

PMID: 26035255

 

Response to Letter Regarding Article, "Heart Failure, Saxagliptin and Diabetes Mellitus: Observations From the SAVOR-TIMI 53 Randomized Trial".

Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg G, Bhatt DL.

Circulation. 2015 Aug 11;132(6):e121-2. doi: 10.1161/CIRCULATIONAHA.115.015511. No abstract available.

PMID: 26260506

 

Targeting the tumor-stromal-immune cell axis.

Gururajan M, Josson S, Chung LW.

Oncoscience. 2015 Aug 11;2(9):743-4. No abstract available.

PMID: 26501076

 

Phase I safety data of lenalidomide, bortezomib, dexamethasone, and elotuzumab as induction therapy for newly diagnosed symptomatic multiple myeloma: SWOG S1211.

Usmani SZ, Sexton R, Ailawadhi S, Shah JJ, Valent J, Rosenzweig M, Lipe B, Zonder JA, Fredette S, Durie B, Hoering A, Bartlett B, Orlowski RZ.

Blood Cancer J. 2015 Aug 7;5:e334. doi: 10.1038/bcj.2015.62. No abstract available.

PMID: 26252787

 

Assessing Hyperspectral Image Content of Pharmaceutical Products Using the Herfindahl-Hirschman Index and Ripley's K-Functions.

Bobiak JP, McGeorge G.

Appl Spectrosc. 2015 Aug;69(8):955-65. doi: 10.1366/14-07650.

PMID: 26163504

 

Biaryls as potent, tunable dual neurokinin 1 receptor antagonists and serotonin transporter inhibitors.

Degnan AP, Tora GO, Han Y, Rajamani R, Bertekap R, Krause R, Davis CD, Hu J, Morgan D, Taylor SJ, Krause K, Li YW, Mattson G, Cunningham MA, Taber MT, Lodge NJ, Bronson JJ, Gillman KW, Macor JE.

Bioorg Med Chem Lett. 2015 Aug 1;25(15):3039-43. doi: 10.1016/j.bmcl.2015.04.098.

PMID: 26048800

 

Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects.

Song Y, Wang X, Perlstein I, Wang J, Badawy S, Frost C, LaCreta F.

Clin Ther. 2015 Aug;37(8):1703-12. doi: 10.1016/j.clinthera.2015.05.497.

PMID: 26188837

 

Costs and Resource Utilization Associated With Anemia and Rash in Chronic Hepatitis C Patients Treated With Direct-Acting Antiviral Agents in the United States.

Le TK, Macaulay D, Kalsekar A, Yuan Y, Sorg RA, Wei J, Wu EQ.

Clin Ther. 2015 Aug;37(8):1713-25.e3. doi: 10.1016/j.clinthera.2015.05.503.

PMID: 26111918

 

Dapagliflozin-induced weight loss affects 24-week glycated haemoglobin and blood pressure levels.

Sjöström CD, Hashemi M, Sugg J, Ptaszynska A, Johnsson E.

Diabetes Obes Metab. 2015 Aug;17(8):809-12. doi: 10.1111/dom.12500.

PMID: 25997813

 

Drug-induced allergic hepatitis develops in mice when myeloid-derived suppressor cells are depleted prior to halothane treatment.

Chakraborty M, Fullerton AM, Semple K, Chea LS, Proctor WR, Bourdi M, Kleiner DE, Zeng X, Ryan PM, Dagur PK, Berkson JD, Reilly TP, Pohl LR.

Hepatology. 2015 Aug;62(2):546-57. doi: 10.1002/hep.27764.

PMID: 25712247

 

Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C.

Ahmad T, Yin P, Saffitz J, Pockros PJ, Lalezari J, Shiffman M, Freilich B, Zamparo J, Brown K, Dimitrova D, Kumar M, Manion D, Heath-Chiozzi M, Wolf R, Hughes E, Muir AJ, Hernandez AF.

Hepatology. 2015 Aug;62(2):409-16. doi: 10.1002/hep.27488.

PMID: 25251156

 

Assessment of the Efficacy and Safety of BMS-820836 in Patients With Treatment-Resistant Major Depression: Results From 2 Randomized, Double-Blind Studies.

Bhagwagar Z, Torbeyns A, Hennicken D, Zheng M, Dunlop BW, Mathew SJ, Khan A, Weisler R, Nelson C, Shelton R, Thase ME, Lane R.

J Clin Psychopharmacol. 2015 Aug;35(4):454-9. doi: 10.1097/JCP.0000000000000335.

PMID: 25961781

 

Increased risk of arterial thromboembolic events after Staphylococcus aureus bacteremia: A matched cohort study.

Mejer N, Gotland N, Uhre ML, Westh H, Schønheyder HC, Petersen A, Jensen AG, Larsen AR, Skov R, Benfield T; Danish Staphylococcal Bacteremia Study Group..

J Infect. 2015 Aug;71(2):167-78. doi: 10.1016/j.jinf.2015.03.010.

PMID: 25936743

 

Synthesis and characterization of tritium labeled N-((R)-1-((S)-4-(4-chlorophenyl)-4-hydroxy-3,3-dimethylpiperidin-1-yl)-3-methyl-1-oxobutan-2-yl)-3-sulfamoylbenzamide.

Hong Y, Hynes J, Tian Y, Balasubramanian B, Bonacorsi S Jr.

J Labelled Comp Radiopharm. 2015 Aug;58(10):414-8. doi: 10.1002/jlcr.3320.

PMID: 26228905

 

Dual Inhibition of Interleukin-23 and Interleukin-17 Offers Superior Efficacy in Mouse Models of Autoimmunity.

Mangan PR, Su LJ, Jenny V, Tatum AL, Picarillo C, Skala S, Ditto N, Lin Z, Yang X, Cotter PZ, Shuster DJ, Song Y, Borowski V, Thomas RL, Heimrich EM, Devaux B, Das Gupta R, Carvajal I, McIntyre KW, Xie J, Zhao Q, Struthers M, Salter-Cid LM.

J Pharmacol Exp Ther. 2015 Aug;354(2):152-65. doi: 10.1124/jpet.115.224246.

PMID: 26015463

 

A randomized, placebo-controlled study of the NS5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1.

Tatum H, Thuluvath PJ, Lawitz E, Martorell C, DeMicco M, Cohen S, Rustgi V, Ravendhran N, Ghalib R, Hanson J, Zamparo J, Zhao J, Cooney E, Treitel M, Hughes E.

J Viral Hepat. 2015 Aug;22(8):658-64. doi: 10.1111/jvh.12372.

PMID: 25496007

 

Evolving synergistic combinations of targeted immunotherapies to combat cancer.

Melero I, Berman DM, Aznar MA, Korman AJ, Pérez Gracia JL, Haanen J.

Nat Rev Cancer. 2015 Aug;15(8):457-72. doi: 10.1038/nrc3973. Review.

PMID: 26205340

 

Development of a Control Strategy for Benzene Impurity in HPMCAS-Stabilized Spray-Dried Dispersion Drug Products Using a Science-Based and Risk-Based Approach.

Yue H, Nicholson SJ, Young JD, Hsieh D, Ketner RJ, Hall RG, Sackett J, Banks EC, Castoro JA, Randazzo ME.

Pharm Res. 2015 Aug;32(8):2636-48. doi: 10.1007/s11095-015-1649-7.

PMID: 25724159

 

Role of Self-Association and Supersaturation in Oral Absorption of a Poorly Soluble Weakly Basic Drug.

Narang AS, Badawy S, Ye Q, Patel D, Vincent M, Raghavan K, Huang Y, Yamniuk A, Vig B, Crison J, Derbin G, Xu Y, Ramirez A, Galella M, Rinaldi FA.

Pharm Res. 2015 Aug;32(8):2579-94. doi: 10.1007/s11095-015-1645-y.

PMID: 25724158

 

Investigation of a Degradant in a Biologics Formulation Buffer Containing L-Histidine.

Wang C, Yamniuk A, Dai J, Chen S, Stetsko P, Ditto N, Zhang Y.

Pharm Res. 2015 Aug;32(8):2625-35. doi: 10.1007/s11095-015-1648-8.

PMID: 25670525

 

Cost-effectiveness Analysis Comparing Apixaban and Acenocoumarol in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation in Spain.

Barón Esquivias G, Escolar Albaladejo G, Zamorano JL, Betegón Nicolás L, Canal Fontcuberta C, de Salas-Cansado M, Rubio-Rodríguez D, Rubio-Terrés C.

Rev Esp Cardiol (Engl Ed). 2015 Aug;68(8):680-90. doi: 10.1016/j.rec.2014.08.010.

PMID: 25498373

 

Agonists of Co-stimulation in Cancer Immunotherapy Directed Against CD137, OX40, GITR, CD27, CD28, and ICOS.

Sanmamed MF, Pastor F, Rodriguez A, Perez-Gracia JL, Rodriguez-Ruiz ME, Jure-Kunkel M, Melero I.

Semin Oncol. 2015 Aug;42(4):640-55. doi: 10.1053/j.seminoncol.2015.05.014. Review.

PMID: 26320067

 

Utilization of the Zucker Diabetic Fatty (ZDF) Rat Model for Investigating Hypoglycemia-related Toxicities.

Tirmenstein M, Horvath J, Graziano M, Mangipudy R, Dorr T, Colman K, Zinker B, Kirby M, Cheng PT, Patrone L, Kozlosky J, Reilly TP, Wang V, Janovitz E.

Toxicol Pathol. 2015 Aug;43(6):825-37. doi: 10.1177/0192623315581020.

PMID: 26085543

 

Checkpoint blockade for cancer therapy: revitalizing a suppressed immune system.

Pico de Coaña Y, Choudhury A, Kiessling R.

Trends Mol Med. 2015 Aug;21(8):482-91. doi: 10.1016/j.molmed.2015.05.005. Review.

PMID: 26091825

 

Prognostic factors for abatacept retention in patients who received at least one prior biologic agent: an interim analysis from the observational, prospective ACTION study.

Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M.

BMC Musculoskelet Disord. 2015 Jul 30;16:176. doi: 10.1186/s12891-015-0636-9.

PMID: 26228643

 

An integrated multi-study analysis of intra-subject variability in cerebrospinal fluid amyloid-β concentrations collected by lumbar puncture and indwelling lumbar catheter.

Lucey BP, Gonzales C, Das U, Li J, Siemers ER, Slemmon JR, Bateman RJ, Huang Y, Fox GB, Claassen JA, Slats D, Verbeek MM, Tong G, Soares H, Savage MJ, Kennedy M, Forman M, Sjögren M, Margolin R, Chen X, Farlow MR, Dean RA, Waring JF.

Alzheimers Res Ther. 2015 Jul 29;7(1):53. doi: 10.1186/s13195-015-0136-z.

PMID: 26225140

 

CXCR4 Regulates Extra-Medullary Myeloma through Epithelial-Mesenchymal-Transition-like Transcriptional Activation.

Roccaro AM, Mishima Y, Sacco A, Moschetta M, Tai YT, Shi J, Zhang Y, Reagan MR, Huynh D, Kawano Y, Sahin I, Chiarini M, Manier S, Cea M, Aljawai Y, Glavey S, Morgan E, Pan C, Michor F, Cardarelli P, Kuhne M, Ghobrial IM.

Cell Rep. 2015 Jul 28;12(4):622-35. doi: 10.1016/j.celrep.2015.06.059.

PMID: 26190113

 

Heterogeneous glycoform separation by process chromatography: I: Monomer purification and characterization.

Li Y, Xu X, Shupe A, Yang R, Bai K, Das T, Borys MC, Li ZJ.

J Chromatogr A. 2015 Jul 24;1404:51-9. doi: 10.1016/j.chroma.2015.05.054.

PMID: 26051082

 

Retrospective analysis of drug utilization, health care resource use, and costs associated with IFN therapy for adjuvant treatment of malignant melanoma.

Zhang Y, Le TK, Shaw JW, Kotapati S.

Clinicoecon Outcomes Res. 2015 Jul 21;7:397-407. doi: 10.2147/CEOR.S78704.

PMID: 26229494

 

Stroke and Bleeding Risk Associated With Antithrombotic Therapy for Patients With Nonvalvular Atrial Fibrillation in Clinical Practice.

An J, Niu F, Lang DT, Jazdzewski KP, Le PT, Rashid N, Meissner B, Mendes R, Dills DG, Aranda G, Bruno A.

J Am Heart Assoc. 2015 Jul 17;4(7). pii: e001921. doi: 10.1161/JAHA.115.001921.

PMID: 26187996

 

Synthesis of Biologically Active Piperidine Metabolites of Clopidogrel: Determination of Structure and Analyte Development.

Shaw SA, Balasubramanian B, Bonacorsi S, Cortes JC, Cao K, Chen BC, Dai J, Decicco C, Goswami A, Guo Z, Hanson R, Humphreys WG, Lam PY, Li W, Mathur A, Maxwell BD, Michaudel Q, Peng L, Pudzianowski A, Qiu F, Su S, Sun D, Tymiak AA, Vokits BP, Wang B, Wexler R, Wu DR, Zhang Y, Zhao R, Baran PS.

J Org Chem. 2015 Jul 17;80(14):7019-32. doi: 10.1021/acs.joc.5b00632. Erratum in: J Org Chem. 2015 Sep 18;80(18):9370.

PMID: 26151079

 

Dihydropyrrolopyrazol-6-one MCHR1 antagonists for the treatment of obesity: Insights on in vivo efficacy from a novel FLIPR assay setup.

Devasthale P, Wang W, Hernandez AS, Moore F, Renduchintala K, Sridhar R, Pelleymounter MA, Longhi D, Huang N, Flynn N, Azzara AV, Rohrbach K, Devenny J, Rooney S, Thomas M, Glick S, Godonis H, Harvey S, Cullen MJ, Zhang H, Caporuscio C, Stetsko P, Grubb M, Huang C, Zhang L, Freeden C, Li YX, Murphy BJ, Robl JA, Washburn WN.

Bioorg Med Chem Lett. 2015 Jul 15;25(14):2793-9. doi: 10.1016/j.bmcl.2015.05.008.

PMID: 26022839

 

9H-Carbazole-1-carboxamides as potent and selective JAK2 inhibitors.

Zimmermann K, Sang X, Mastalerz HA, Johnson WL, Zhang G, Liu Q, Batt D, Lombardo LJ, Vyas D, Trainor GL, Tokarski JS, Lorenzi MV, You D, Gottardis MM, Lippy J, Khan J, Sack JS, Purandare AV.

Bioorg Med Chem Lett. 2015 Jul 15;25(14):2809-12. doi: 10.1016/j.bmcl.2015.04.101.

PMID: 25987372

 

Current complexity: a tool for assessing the complexity of organic molecules.

Li J, Eastgate MD.

Org Biomol Chem. 2015 Jul 14;13(26):7164-76. doi: 10.1039/c5ob00709g.

PMID: 25962620

 

Discovery of a Highly Selective JAK2 Inhibitor, BMS-911543, for the Treatment of Myeloproliferative Neoplasms.

Wan H, Schroeder GM, Hart AC, Inghrim J, Grebinski J, Tokarski JS, Lorenzi MV, You D, Mcdevitt T, Penhallow B, Vuppugalla R, Zhang Y, Gu X, Iyer R, Lombardo LJ, Trainor GL, Ruepp S, Lippy J, Blat Y, Sack JS, Khan JA, Stefanski K, Sleczka B, Mathur A, Sun JH, Wong MK, Wu DR, Li P, Gupta A, Arunachalam PN, Pragalathan B, Narayanan S, K C N, Kuppusamy P, Purandare AV.

ACS Med Chem Lett. 2015 Jul 12;6(8):850-5. doi: 10.1021/acsmedchemlett.5b00226.

PMID: 26288683

 

Structure-Based Design of Selective Janus Kinase 2 Imidazo[4,5-d]pyrrolo[2,3-b]pyridine Inhibitors.

Hart AC, Schroeder GM, Wan H, Grebinski J, Inghrim J, Kempson J, Guo J, Pitts WJ, Tokarski JS, Sack JS, Khan JA, Lippy J, Lorenzi MV, You D, McDevitt T, Vuppugalla R, Zhang Y, Lombardo LJ, Trainor GL, Purandare AV.

ACS Med Chem Lett. 2015 Jul 10;6(8):845-9. doi: 10.1021/acsmedchemlett.5b00225.

PMID: 26288682

 

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.

Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR.

N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627.

PMID: 26028407

 

Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma.

Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD.

N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030.

PMID: 26027431

 

Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models.

Mathias N, Xu Y, Vig B, Kestur U, Saari A, Crison J, Desai D, Vanarase A, Hussain M.

AAPS J. 2015 Jul;17(4):988-98. doi: 10.1208/s12248-015-9759-z.

PMID: 25933598

 

Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.

Ni YG, Yuan X, Newitt JA, Peterson JE, Gleason CR, Haulenbeek J, Santockyte R, Lafont V, Marsilio F, Neely RJ, DeSilva B, Piccoli SP.

AAPS J. 2015 Jul;17(4):976-87. doi: 10.1208/s12248-015-9762-4.

PMID: 25924887

 

High Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms.

McPhee F, Suzuki Y, Toyota J, Karino Y, Chayama K, Kawakami Y, Yu ML, Ahn SH, Ishikawa H, Bhore R, Zhou N, Hernandez D, Mendez P, Kumada H.

Adv Ther. 2015 Jul;32(7):637-49. doi: 10.1007/s12325-015-0221-5.

PMID: 26155891

 

Perspective: The Alzheimer's Disease Neuroimaging Initiative and the role and contributions of the Private Partner Scientific Board (PPSB).

Liu E, Luthman J, Cedarbaum JM, Schmidt ME, Cole PE, Hendrix J, Carrillo MC, Jones-Davis D, Tarver E, Novak G, De Santi S, Soares HD, Potter WZ, Siemers E, Schwarz AJ.

Alzheimers Dement. 2015 Jul;11(7):840-9. doi: 10.1016/j.jalz.2015.04.001. Review.

PMID: 26194317

 

Genetic studies of quantitative MCI and AD phenotypes in ADNI: Progress, opportunities, and plans.

Saykin AJ, Shen L, Yao X, Kim S, Nho K, Risacher SL, Ramanan VK, Foroud TM, Faber KM, Sarwar N, Munsie LM, Hu X, Soares HD, Potkin SG, Thompson PM, Kauwe JS, Kaddurah-Daouk R, Green RC, Toga AW, Weiner MW; Alzheimer's Disease Neuroimaging Initiative..

Alzheimers Dement. 2015 Jul;11(7):792-814. doi: 10.1016/j.jalz.2015.05.009. Review.

PMID: 26194313

 

The Alzheimer's Disease Neuroimaging Initiative 2 Biomarker Core: A review of progress and plans.

Kang JH, Korecka M, Figurski MJ, Toledo JB, Blennow K, Zetterberg H, Waligorska T, Brylska M, Fields L, Shah N, Soares H, Dean RA, Vanderstichele H, Petersen RC, Aisen PS, Saykin AJ, Weiner MW, Trojanowski JQ, Shaw LM; Alzheimer's Disease Neuroimaging Initiative..

Alzheimers Dement. 2015 Jul;11(7):772-91. doi: 10.1016/j.jalz.2015.05.003. Review.

PMID: 26194312

 

Warfarin and Aspirin Use for Stroke Prevention Among Patients With Atrial Fibrillation: The US National Health and Wellness Survey.

Goren A, Liu X, Gupta S, Simon TA, Phatak H.

Am J Ther. 2015 Jul-Aug;22(4):248-56. doi: 10.1097/MJT.0000000000000001.

PMID: 24326696

 

Pharmacokinetic interactions between BMS-626529, the active moiety of the HIV-1 attachment inhibitor prodrug BMS-663068, and ritonavir or ritonavir-boosted atazanavir in healthy subjects.

Zhu L, Hruska M, Hwang C, Shah V, Furlong M, Hanna GJ, Bertz R, Landry IS.

Antimicrob Agents Chemother. 2015 Jul;59(7):3816-22. doi: 10.1128/AAC.04914-14.

PMID: 25870057

 

 

Development and scale-up of the recovery and purification of a domain antibody Fc fusion protein-comparison of a two and three-step approach.

Herzer S, Bhangale A, Barker G, Chowdhary I, Conover M, O'Mara BW, Tsang L, Wang SY, Krystek SR Jr, Yao Y, Rieble S.

Biotechnol Bioeng. 2015 Jul;112(7):1417-28. doi: 10.1002/bit.25561.

PMID: 25683677

 

Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW.

Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004.

PMID: 26048185

 

The cost-effectiveness of dapagliflozin versus sulfonylurea as an add-on to metformin in the treatment of Type 2 diabetes mellitus.

Charokopou M, McEwan P, Lister S, Callan L, Bergenheim K, Tolley K, Postema R, Townsend R, Roudaut M.

Diabet Med. 2015 Jul;32(7):890-8. doi: 10.1111/dme.12772.

PMID: 25817050

 

Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study.

Schernthaner G, Rosas-Guzmán J, Dotta F, Guerci B, Simó R, Festa A, Kiljański J, Zhou M, Gallwitz B.

Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471.

PMID: 25846577

 

Characterization of Organic Anion Transporter 2 (SLC22A7): A Highly Efficient Transporter for Creatinine and Species-Dependent Renal Tubular Expression.

Shen H, Liu T, Morse BL, Zhao Y, Zhang Y, Qiu X, Chen C, Lewin AC, Wang XT, Liu G, Christopher LJ, Marathe P, Lai Y.

Drug Metab Dispos. 2015 Jul;43(7):984-93. doi: 10.1124/dmd.114.062364.

PMID: 25904762

 

Comparison of thromboprophylaxis patterns in arthroplasty in public and private hospitals.

Cortada AP, Silva TG, Silva AC, Golmia RP, Guerra RL, Takemoto ML, Monteiro RD, Scheinberg MA.

Einstein (Sao Paulo). 2015 Jul-Sep;13(3):410-6. doi: 10.1590/S1679-45082015GS3057. English, Portuguese.

PMID: 26313439

 

 

Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer.

McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I.

Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026.

PMID: 25925990

 

Cytokines: The Good, the Bad, and the Deadly.

Ramani T, Auletta CS, Weinstock D, Mounho-Zamora B, Ryan PC, Salcedo TW, Bannish G.

Int J Toxicol. 2015 Jul-Aug;34(4):355-65. doi: 10.1177/1091581815584918.

PMID: 26015504

 

Hydromethylation of Unactivated Olefins.

Dao HT, Li C, Michaudel Q, Maxwell BD, Baran PS.

J Am Chem Soc. 2015 Jul 1;137(25):8046-9. doi: 10.1021/jacs.5b05144.

PMID: 26088401

 

D-α-tocopheryl polyethylene glycol 1000 succinate-containing vehicles provide no detectable chemoprotection from oxidative damage.

Baumgart BR, Van Vleet TR, Simic D, Salcedo TW, Lentz K, Donegan M, Davies MH, Bunch RT, Sanderson TP, Lange RW.

J Appl Toxicol. 2015 Jul;35(7):791-8. doi: 10.1002/jat.3072.

PMID: 25348750

 

Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide Once Weekly for the Treatment of Type 2 Diabetes.

LaRue S, Malloy J.

J Diabetes Sci Technol. 2015 Jul;9(4):815-21. doi: 10.1177/1932296815576186.

PMID: 25759181

 

Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders.

Jensen D, Sherman KE, Hézode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team..

J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018.

PMID: 25703086

 

Synthesis of stable isotope-labeled epothilone D using a degradation-reconstruction approach.

Burrell RC, Turley WA, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2015 Jul;58(9):361-9. doi: 10.1002/jlcr.3312.

PMID: 26158758

 

Wetting effects versus ion pairs diffusivity: interactions of anionic surfactants with highly soluble cationic drugs and its impact on tablet dissolution.

Desai D, Wong B, Huang Y, Ye Q, Guo H, Huang M, Timmins P.

J Pharm Sci. 2015 Jul;104(7):2255-65. doi: 10.1002/jps.24478.

PMID: 26017286

 

Evaluating scale-up rules of a high-shear wet granulation process.

Tao J, Pandey P, Bindra DS, Gao JZ, Narang AS.

J Pharm Sci. 2015 Jul;104(7):2323-33. doi: 10.1002/jps.24504.

PMID: 26010137

 

Implementation of Amplicon Parallel Sequencing Leads to Improvement of Diagnosis and Therapy of Lung Cancer Patients.

König K, Peifer M, Fassunke J, Ihle MA, Künstlinger H, Heydt C, Stamm K, Ueckeroth F, Vollbrecht C, Bos M, Gardizi M, Scheffler M, Nogova L, Leenders F, Albus K, Meder L, Becker K, Florin A, Rommerscheidt-Fuss U, Altmüller J, Kloth M, Nürnberg P, Henkel T, Bikár SE, Sos ML, Geese WJ, Strauss L, Ko YD, Gerigk U, Odenthal M, Zander T, Wolf J, Merkelbach-Bruse S, Buettner R, Heukamp LC.

J Thorac Oncol. 2015 Jul;10(7):1049-57. doi: 10.1097/JTO.0000000000000570.

PMID: 26102443

 

Efficacy and Safety of Nivolumab in Patients With BRAF V600 Mutant and BRAF Wild-Type Advanced Melanoma: A Pooled Analysis of 4 Clinical Trials.

Larkin J, Lao CD, Urba WJ, McDermott DF, Horak C, Jiang J, Wolchok JD.

JAMA Oncol. 2015 Jul;1(4):433-40. doi: 10.1001/jamaoncol.2015.1184.

PMID: 26181250