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Items: 27

1.

Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance.

Kenny JR, Ramsden D, Buckley DB, Dallas S, Fung C, Mohutsky M, Einolf HJ, Chen L, Dekeyser JG, Fitzgerald M, Goosen TC, Siu YA, Walsky RL, Zhang G, Tweedie D, Hariparsad N.

Drug Metab Dispos. 2018 Sep;46(9):1285-1303. doi: 10.1124/dmd.118.081927. Epub 2018 Jun 29.

PMID:
29959133
2.

Pharmacokinetics of the natural antibiotic negamycin.

Guo J, Miele EW, Chen A, Luzietti RA, Zambrowski M, Walsky RL, Buurman ET.

Xenobiotica. 2015;45(7):625-33. doi: 10.3109/00498254.2015.1006301. Epub 2015 Mar 3.

PMID:
25733027
3.

Contribution of metabolites to P450 inhibition-based drug-drug interactions: scholarship from the drug metabolism leadership group of the innovation and quality consortium metabolite group.

Yu H, Balani SK, Chen W, Cui D, He L, Humphreys WG, Mao J, Lai WG, Lee AJ, Lim HK, MacLauchlin C, Prakash C, Surapaneni S, Tse S, Upthagrove A, Walsky RL, Wen B, Zeng Z.

Drug Metab Dispos. 2015 Apr;43(4):620-30. doi: 10.1124/dmd.114.059345. Epub 2015 Feb 5.

PMID:
25655830
4.

Relative contributions of cytochrome CYP3A4 versus CYP3A5 for CYP3A-cleared drugs assessed in vitro using a CYP3A4-selective inactivator (CYP3cide).

Tseng E, Walsky RL, Luzietti RA Jr, Harris JJ, Kosa RE, Goosen TC, Zientek MA, Obach RS.

Drug Metab Dispos. 2014 Jul;42(7):1163-73. doi: 10.1124/dmd.114.057000. Epub 2014 Apr 15.

PMID:
24737844
5.

Early prediction of polymyxin-induced nephrotoxicity with next-generation urinary kidney injury biomarkers.

Keirstead ND, Wagoner MP, Bentley P, Blais M, Brown C, Cheatham L, Ciaccio P, Dragan Y, Ferguson D, Fikes J, Galvin M, Gupta A, Hale M, Johnson N, Luo W, McGrath F, Pietras M, Price S, Sathe AG, Sasaki JC, Snow D, Walsky RL, Kern G.

Toxicol Sci. 2014 Feb;137(2):278-91. doi: 10.1093/toxsci/kft247. Epub 2013 Nov 4.

PMID:
24189134
6.

Elucidation of the biochemical basis for a clinical drug-drug interaction between atorvastatin and 5-(N-(4-((4-ethylbenzyl)thio)phenyl)sulfamoyl)-2-methyl benzoic acid (CP-778875), a subtype selective agonist of the peroxisome proliferator-activated receptor alpha.

Kalgutkar AS, Chen D, Varma MV, Feng B, Terra SG, Scialis RJ, Rotter CJ, Frederick KS, West MA, Goosen TC, Gosset JR, Walsky RL, Francone OL.

Xenobiotica. 2013 Nov;43(11):963-72. doi: 10.3109/00498254.2013.791004. Epub 2013 Apr 30.

PMID:
23631744
7.

Selective mechanism-based inactivation of CYP3A4 by CYP3cide (PF-04981517) and its utility as an in vitro tool for delineating the relative roles of CYP3A4 versus CYP3A5 in the metabolism of drugs.

Walsky RL, Obach RS, Hyland R, Kang P, Zhou S, West M, Geoghegan KF, Helal CJ, Walker GS, Goosen TC, Zientek MA.

Drug Metab Dispos. 2012 Sep;40(9):1686-97. doi: 10.1124/dmd.112.045302. Epub 2012 May 29.

PMID:
22645092
8.

Optimized assays for human UDP-glucuronosyltransferase (UGT) activities: altered alamethicin concentration and utility to screen for UGT inhibitors.

Walsky RL, Bauman JN, Bourcier K, Giddens G, Lapham K, Negahban A, Ryder TF, Obach RS, Hyland R, Goosen TC.

Drug Metab Dispos. 2012 May;40(5):1051-65. doi: 10.1124/dmd.111.043117. Epub 2012 Feb 22.

PMID:
22357286
9.

Lack of effect of tofacitinib (CP-690,550) on the pharmacokinetics of the CYP3A4 substrate midazolam in healthy volunteers: confirmation of in vitro data.

Gupta P, Alvey C, Wang R, Dowty ME, Fahmi OA, Walsky RL, Riese RJ, Krishnaswami S.

Br J Clin Pharmacol. 2012 Jul;74(1):109-15. doi: 10.1111/j.1365-2125.2012.04168.x.

10.

Preclinical species and human disposition of PF-04971729, a selective inhibitor of the sodium-dependent glucose cotransporter 2 and clinical candidate for the treatment of type 2 diabetes mellitus.

Kalgutkar AS, Tugnait M, Zhu T, Kimoto E, Miao Z, Mascitti V, Yang X, Tan B, Walsky RL, Chupka J, Feng B, Robinson RP.

Drug Metab Dispos. 2011 Sep;39(9):1609-19. doi: 10.1124/dmd.111.040675. Epub 2011 Jun 20.

PMID:
21690265
11.

Prediction of time-dependent CYP3A4 drug-drug interactions by physiologically based pharmacokinetic modelling: impact of inactivation parameters and enzyme turnover.

Rowland Yeo K, Walsky RL, Jamei M, Rostami-Hodjegan A, Tucker GT.

Eur J Pharm Sci. 2011 Jun 14;43(3):160-73. doi: 10.1016/j.ejps.2011.04.008. Epub 2011 Apr 20.

PMID:
21540107
12.

Measurement of in vitro cytochrome P450 2B6 activity.

Walsky RL, Obach RS.

Curr Protoc Toxicol. 2009;Chapter 4:Unit4.27. doi: 10.1002/0471140856.tx0427s39.

PMID:
23045012
13.

In vitro and in vivo studies to characterize the clearance mechanism and potential cytochrome P450 interactions of anidulafungin.

Damle BD, Dowell JA, Walsky RL, Weber GL, Stogniew M, Inskeep PB.

Antimicrob Agents Chemother. 2009 Mar;53(3):1149-56. doi: 10.1128/AAC.01279-08. Epub 2008 Nov 24.

14.

In vitro cytochrome P450 inhibition and induction.

Walsky RL, Boldt SE.

Curr Drug Metab. 2008 Nov;9(9):928-39. Review.

PMID:
18991590
15.

Comparison of the bioactivation potential of the antidepressant and hepatotoxin nefazodone with aripiprazole, a structural analog and marketed drug.

Bauman JN, Frederick KS, Sawant A, Walsky RL, Cox LM, Obach RS, Kalgutkar AS.

Drug Metab Dispos. 2008 Jun;36(6):1016-29. doi: 10.1124/dmd.108.020545. Epub 2008 Mar 10.

PMID:
18332080
16.

Lack of pharmacokinetic and pharmacodynamic interactions between a smoking cessation therapy, varenicline, and warfarin: an in vivo and in vitro study.

Burstein AH, Clark DJ, O'Gorman M, Willavize SA, Brayman TG, Grover GS, Walsky RL, Obach RS, Faessel HM.

J Clin Pharmacol. 2007 Nov;47(11):1421-9.

PMID:
17962429
18.

Evaluation of 227 drugs for in vitro inhibition of cytochrome P450 2B6.

Walsky RL, Astuccio AV, Obach RS.

J Clin Pharmacol. 2006 Dec;46(12):1426-38.

PMID:
17101742
19.

Mechanism-based inactivation of human cytochrome p450 enzymes and the prediction of drug-drug interactions.

Obach RS, Walsky RL, Venkatakrishnan K.

Drug Metab Dispos. 2007 Feb;35(2):246-55. Epub 2006 Nov 8.

PMID:
17093004
20.

Effects of steady-state lasofoxifene on CYP2D6- and CYP2E1-mediated metabolism.

Moller RA, Fisher JM, Taylor AE, Kolluri S, Gardner MJ, Obach RS, Walsky RL.

Ann Pharmacother. 2006 Jan;40(1):32-7. Epub 2005 Dec 20.

PMID:
16368922
21.

In vitro cytochrome P450 inhibition data and the prediction of drug-drug interactions: qualitative relationships, quantitative predictions, and the rank-order approach.

Obach RS, Walsky RL, Venkatakrishnan K, Houston JB, Tremaine LM.

Clin Pharmacol Ther. 2005 Dec;78(6):582-92. Review. No abstract available.

PMID:
16338274
23.

The utility of in vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions.

Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, Tremaine LM.

J Pharmacol Exp Ther. 2006 Jan;316(1):336-48. Epub 2005 Sep 28.

PMID:
16192315
24.

Selective inhibition of human cytochrome P4502C8 by montelukast.

Walsky RL, Obach RS, Gaman EA, Gleeson JP, Proctor WR.

Drug Metab Dispos. 2005 Mar;33(3):413-8. Epub 2004 Dec 17.

PMID:
15608135
25.

Examination of 209 drugs for inhibition of cytochrome P450 2C8.

Walsky RL, Gaman EA, Obach RS.

J Clin Pharmacol. 2005 Jan;45(1):68-78.

PMID:
15601807
26.

Validated assays for human cytochrome P450 activities.

Walsky RL, Obach RS.

Drug Metab Dispos. 2004 Jun;32(6):647-60.

PMID:
15155557
27.

Verification of the selectivity of (+)N-3-benzylnirvanol as a CYP2C19 inhibitor.

Walsky RL, Obach RS.

Drug Metab Dispos. 2003 Mar;31(3):343. No abstract available.

PMID:
12625332

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