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

• Published in: Journal of clinical pharmacology Vol. 60 Suppl 1; p. S160
• Main Authors: Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Fan, Jianghong, Grillo, Joseph A, Huang, Shiew-Mei, Zhu, Hao, Wang, Yaning
• Format: Journal Article
• Language: English
• Published: England 01.10.2020
• Subjects: modeling and simulation; PBPK; drug-drug interactions; pharmacokinetics and drug metabolism; clinical pharmacology (CPH); MIDD (model-informed drug development)

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 Pharmac...