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Items: 20

1.

Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis.

Shebley M, Polepally AR, Nader A, Ng JW, Winzenborg I, Klein CE, Noertersheuser P, Gibbs MA, Mostafa NM.

Clin Pharmacokinet. 2020 Mar;59(3):297-309. doi: 10.1007/s40262-019-00840-7. Review.

2.

Quantitative Assessment of Elagolix Enzyme-Transporter Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling.

Chiney MS, Ng J, Gibbs JP, Shebley M.

Clin Pharmacokinet. 2019 Nov 12. doi: 10.1007/s40262-019-00833-6. [Epub ahead of print]

PMID:
31713224
3.

Practical Assessment of Clinical Drug-Drug Interactions in Drug Development Using Physiologically Based Pharmacokinetics Modeling.

Shebley M, Einolf HJ.

Clin Pharmacol Ther. 2019 Jun;105(6):1326-1328. doi: 10.1002/cpt.1394. Epub 2019 Mar 20. Review. No abstract available.

PMID:
30893473
4.

Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse.

Shebley M, Menon RM, Gibbs JP, Dave N, Kim SY, Marroum PJ.

J Clin Pharmacol. 2019 May;59(5):625-637. doi: 10.1002/jcph.1359. Epub 2018 Dec 18. Review.

5.

Interaction of Dasabuvir With Clopidogrel: Did Predictions by Physiologically Based Pharmacokinetics Modeling Pass the Test?

Shebley M.

Clin Pharmacol Ther. 2019 Feb;105(2):320-321. doi: 10.1002/cpt.1196. Epub 2018 Sep 17. No abstract available.

6.

Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies.

Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J.

Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29.

7.

Industry Perspective on Standardizing Food-Effect Studies for New Drug Development.

Marroum PJ, Nuthalapati S, Parikh A, Shebley M, Hoffman D, Zha J, Khatri A, Awni WM.

Clin Pharmacokinet. 2018 Aug;57(8):901-909. doi: 10.1007/s40262-018-0630-0. Review.

PMID:
29460023
8.

Guiding dose adjustment of amlodipine after co-administration with ritonavir containing regimens using a physiologically-based pharmacokinetic/pharmacodynamic model.

Mukherjee D, Zha J, Menon RM, Shebley M.

J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):443-456. doi: 10.1007/s10928-018-9574-0. Epub 2018 Feb 9.

9.

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.

Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M.

Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Review.

10.

Mechanisms and Predictions of Drug-Drug Interactions of the Hepatitis C Virus Three Direct-Acting Antiviral Regimen: Paritaprevir/Ritonavir, Ombitasvir, and Dasabuvir.

Shebley M, Liu J, Kavetskaia O, Sydor J, de Morais SM, Fischer V, Nijsen MJMA, Bow DAJ.

Drug Metab Dispos. 2017 Jul;45(7):755-764. doi: 10.1124/dmd.116.074518. Epub 2017 May 8.

PMID:
28483778
11.

Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction Between Clopidogrel and Dasabuvir.

Shebley M, Fu W, Badri P, Bow D, Fischer V.

Clin Pharmacol Ther. 2017 Oct;102(4):679-687. doi: 10.1002/cpt.689. Epub 2017 Jun 3.

12.

Response to "Quantitative Prediction of Drug-Drug Interactions Involving Inhibitory Metabolites by Physiologically Based Pharmacokinetic Models: Is It Worth?"

Templeton IE, Chen Y, Mao J, Lin J, Yu H, Peters S, Shebley M, Varma MV.

CPT Pharmacometrics Syst Pharmacol. 2017 Apr;6(4):227. doi: 10.1002/psp4.12183. No abstract available.

13.

Quantitative Prediction of the Effect of CYP3A Inhibitors and Inducers on Venetoclax Pharmacokinetics Using a Physiologically Based Pharmacokinetic Model.

Freise KJ, Shebley M, Salem AH.

J Clin Pharmacol. 2017 Jun;57(6):796-804. doi: 10.1002/jcph.858. Epub 2017 Jan 4.

PMID:
28052338
14.

Quantitative Prediction of Drug-Drug Interactions Involving Inhibitory Metabolites in Drug Development: How Can Physiologically Based Pharmacokinetic Modeling Help?

Templeton IE, Chen Y, Mao J, Lin J, Yu H, Peters S, Shebley M, Varma MV.

CPT Pharmacometrics Syst Pharmacol. 2016 Oct;5(10):505-515. doi: 10.1002/psp4.12110. Epub 2016 Sep 19.

15.

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. Epub 2016 Jul 15.

PMID:
27422672
16.

Synthesis and Pharmacology of (Pyridin-2-yl)methanol Derivatives as Novel and Selective Transient Receptor Potential Vanilloid 3 Antagonists.

Gomtsyan A, Schmidt RG, Bayburt EK, Gfesser GA, Voight EA, Daanen JF, Schmidt DL, Cowart MD, Liu H, Altenbach RJ, Kort ME, Clapham B, Cox PB, Shrestha A, Henry R, Whittern DN, Reilly RM, Puttfarcken PS, Brederson JD, Song P, Li B, Huang SM, McDonald HA, Neelands TR, McGaraughty SP, Gauvin DM, Joshi SK, Banfor PN, Segreti JA, Shebley M, Faltynek CR, Dart MJ, Kym PR.

J Med Chem. 2016 May 26;59(10):4926-47. doi: 10.1021/acs.jmedchem.6b00287. Epub 2016 May 2.

PMID:
27077528
17.

Evaluation of various static and dynamic modeling methods to predict clinical CYP3A induction using in vitro CYP3A4 mRNA induction data.

Einolf HJ, Chen L, Fahmi OA, Gibson CR, Obach RS, Shebley M, Silva J, Sinz MW, Unadkat JD, Zhang L, Zhao P.

Clin Pharmacol Ther. 2014 Feb;95(2):179-88. doi: 10.1038/clpt.2013.170. Epub 2013 Aug 29.

PMID:
23995268
18.

Mechanistic analysis of the inactivation of cytochrome P450 2B6 by phencyclidine: effects on substrate binding, electron transfer, and uncoupling.

Shebley M, Kent UM, Ballou DP, Hollenberg PF.

Drug Metab Dispos. 2009 Apr;37(4):745-52. doi: 10.1124/dmd.108.024661. Epub 2009 Jan 14.

19.

Mutation of a single residue (K262R) in P450 2B6 leads to loss of mechanism-based inactivation by phencyclidine.

Shebley M, Hollenberg PF.

Drug Metab Dispos. 2007 Aug;35(8):1365-71. Epub 2007 Apr 25.

PMID:
17460030
20.

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