Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA’s Office of Clinical Pharmacology

Authors: Zhang X, Yang Y, Grimstein M, Fan J, Grillo JA, Huang SM, Zhu H, Wang Y
Publication: J Am Coll Clin Pharm
Keywords: clinical pharmacology (CPH), Drug-drug interactions, MIDD (model-informed drug development), modeling and simulation, PBPK, pharmacokinetics and drug metabolism
Software: GastroPlus®

Abstract

Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration’s Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modeling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In this commentary, we provide an update on the application of PBPK modeling in submissions received between 2018 and 2019 and highlight a few notable examples.

By Xinyuan Zhang, Yuching Yang, Manuela Grimstein, Jianghong Fan, Joseph A. Grillo, Shiew-Mei Huang, Hao Zhu, and Yaning Wang