Physiologically based pharmacokinetic model qualification and reporting procedures for regulatory submissions: a consortium perspective M Shebley, P Sandhu, A Emami Riedmaier, M Jamei, R Narayanan, ... Clinical Pharmacology & Therapeutics 104 (1), 88-110, 2018 | 296 | 2018 |
Evaluation of Various Static and Dynamic Modeling Methods to Predict Clinical CYP3A Induction Using In Vitro CYP3A4 mRNA Induction Data HJ Einolf, L Chen, OA Fahmi, CR Gibson, RS Obach, M Shebley, J Silva, ... Clinical Pharmacology & Therapeutics 95 (2), 179-188, 2014 | 84 | 2014 |
Physiologically‐based pharmacokinetic modeling in renal and hepatic impairment populations: a pharmaceutical industry perspective T Heimbach, Y Chen, J Chen, V Dixit, N Parrott, SA Peters, I Poggesi, ... Clinical Pharmacology & Therapeutics 110 (2), 297-310, 2021 | 72 | 2021 |
Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies AE Place, K Goldsmith, JP Bourquin, ML Loh, L Gore, DA Morgenstern, ... Future Oncology 14 (21), 2115-2129, 2018 | 57 | 2018 |
Quantitative prediction of the effect of CYP3A inhibitors and inducers on venetoclax pharmacokinetics using a physiologically based pharmacokinetic model KJ Freise, M Shebley, AH Salem The Journal of Clinical Pharmacology 57 (6), 796-804, 2017 | 57 | 2017 |
Clinical pharmacology of elagolix: an oral gonadotropin-releasing hormone receptor antagonist for endometriosis M Shebley, AR Polepally, A Nader, JW Ng, I Winzenborg, CE Klein, ... Clinical pharmacokinetics 59 (3), 297-309, 2020 | 49 | 2020 |
Evaluation of CYP2B6 induction and prediction of clinical drug–drug interactions: considerations from the IQ consortium induction working group—an industry perspective OA Fahmi, M Shebley, J Palamanda, MW Sinz, D Ramsden, HJ Einolf, ... Drug Metabolism and Disposition 44 (10), 1720-1730, 2016 | 41 | 2016 |
Mechanisms and predictions of drug-drug interactions of the hepatitis C virus three direct-acting antiviral regimen: paritaprevir/ritonavir, ombitasvir, and dasabuvir M Shebley, J Liu, O Kavetskaia, J Sydor, SM de Morais, V Fischer, ... Drug Metabolism and Disposition 45 (7), 755-764, 2017 | 38 | 2017 |
Synthesis and pharmacology of (pyridin-2-yl) methanol derivatives as novel and selective transient receptor potential vanilloid 3 antagonists A Gomtsyan, RG Schmidt, EK Bayburt, GA Gfesser, EA Voight, JF Daanen, ... Journal of medicinal chemistry 59 (10), 4926-4947, 2016 | 36 | 2016 |
Selective pathways for the metabolism of phencyclidine by cytochrome p450 2b enzymes: identification of electrophilic metabolites, glutathione, and N-acetyl cysteine adducts M Shebley, MI Jushchyshyn, PF Hollenberg Drug metabolism and Disposition 34 (3), 375-383, 2006 | 35 | 2006 |
Physiologically based pharmacokinetic modeling suggests limited drug–drug interaction between clopidogrel and dasabuvir M Shebley, W Fu, P Badri, DAJ Bow, V Fischer Clinical Pharmacology & Therapeutics 102 (4), 679-687, 2017 | 31 | 2017 |
A mechanistic non-clinical assessment of drug-drug interactions (metabolism and transporters) with the hepatitis C virus (HCV) regimen: ABT-450/r, ombitasvir and dasabuvir DAJ Bow, J Liu, O Kavetskaia, R Menon, SM de Morais, M Nijsen, J Sydor, ... Poster presented at, 2014 | 28 | 2014 |
Mechanistic analysis of the inactivation of cytochrome P450 2B6 by phencyclidine: effects on substrate binding, electron transfer, and uncoupling M Shebley, UM Kent, DP Ballou, PF Hollenberg Drug metabolism and disposition 37 (4), 745-752, 2009 | 25 | 2009 |
Quantitative Prediction of Drug–Drug Interactions Involving Inhibitory Metabolites in Drug Development: How Can Physiologically Based Pharmacokinetic Modeling Help? IE Templeton, Y Chen, J Mao, J Lin, H Yu, S Peters, M Shebley, ... CPT: Pharmacometrics & Systems Pharmacology 5 (10), 505-515, 2016 | 21 | 2016 |
Guiding dose adjustment of amlodipine after co-administration with ritonavir containing regimens using a physiologically-based pharmacokinetic/pharmacodynamic model D Mukherjee, J Zha, RM Menon, M Shebley Journal of pharmacokinetics and pharmacodynamics 45, 443-456, 2018 | 20 | 2018 |
Quantitative assessment of elagolix enzyme-transporter interplay and drug–drug interactions using physiologically based pharmacokinetic modeling MS Chiney, J Ng, JP Gibbs, M Shebley Clinical Pharmacokinetics 59 (5), 617-627, 2020 | 18 | 2020 |
Bone mineral density changes associated with pregnancy, lactation, and medical treatments in premenopausal women and effects later in life NB Watts, N Binkley, CD Owens, A Al-Hendy, EE Puscheck, M Shebley, ... Journal of women's health 30 (10), 1416-1430, 2021 | 17 | 2021 |
Mutation of a single residue (K262R) in P450 2B6 leads to loss of mechanism-based inactivation by phencyclidine M Shebley, PF Hollenberg Drug metabolism and disposition 35 (8), 1365-1371, 2007 | 16 | 2007 |
Assessment of clinical drug‐drug interactions of elagolix, a gonadotropin‐releasing hormone receptor antagonist AR Polepally, JW Ng, AH Salem, MB Dufek, A Parikh, DC Carter, ... The Journal of Clinical Pharmacology 60 (12), 1606-1616, 2020 | 14 | 2020 |
Accelerating drug development in pediatric oncology with the clinical pharmacology storehouse M Shebley, RM Menon, JP Gibbs, N Dave, SY Kim, PJ Marroum The Journal of Clinical Pharmacology 59 (5), 625-637, 2019 | 13 | 2019 |