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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. Shebley M, et al. Among authors: chen j, chen y. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29315504 Free PMC article. Review.
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. Bohnert T, et al. Among authors: chen y. Drug Metab Dispos. 2016 Aug;44(8):1399-423. doi: 10.1124/dmd.115.069096. Epub 2016 Apr 6. Drug Metab Dispos. 2016. PMID: 27052879 Review.
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. Templeton IE, et al. Among authors: chen y. CPT Pharmacometrics Syst Pharmacol. 2016 Oct;5(10):505-515. doi: 10.1002/psp4.12110. Epub 2016 Sep 19. CPT Pharmacometrics Syst Pharmacol. 2016. PMID: 27642087 Free PMC article.
Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.
Chen Y, Cabalu TD, Callegari E, Einolf H, Liu L, Parrott N, Peters SA, Schuck E, Sharma P, Tracey H, Upreti VV, Zheng M, Zhu AZX, Hall SD. Chen Y, et al. CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):685-695. doi: 10.1002/psp4.12449. Epub 2019 Aug 7. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31215774 Free PMC article.
Physiologically-Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug-Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations.
Taskar KS, Pilla Reddy V, Burt H, Posada MM, Varma M, Zheng M, Ullah M, Emami Riedmaier A, Umehara KI, Snoeys J, Nakakariya M, Chu X, Beneton M, Chen Y, Huth F, Narayanan R, Mukherjee D, Dixit V, Sugiyama Y, Neuhoff S. Taskar KS, et al. Among authors: chen y. Clin Pharmacol Ther. 2020 May;107(5):1082-1115. doi: 10.1002/cpt.1693. Epub 2019 Dec 31. Clin Pharmacol Ther. 2020. PMID: 31628859 Free PMC article. Review.
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