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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.
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.
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.
Heimbach T, Chen Y, Chen J, Dixit V, Parrott N, Peters SA, Poggesi I, Sharma P, Snoeys J, Shebley M, Tai G, Tse S, Upreti VV, Wang YH, Tsai A, Xia B, Zheng M, Zhu AZX, Hall S. Heimbach T, et al. Among authors: chen j, chen y. Clin Pharmacol Ther. 2021 Aug;110(2):297-310. doi: 10.1002/cpt.2125. Epub 2020 Dec 30. Clin Pharmacol Ther. 2021. PMID: 33270249 Free PMC article.
Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: chen y. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.
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