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 - Zhang, Xinyuan; Yang, Yuching; Grimstein, Manuela; Fan, Jianghong; Grillo, Joseph A; Huang, Shiew-Mei; Zhu, Hao; Wang, Yaning (Journal of clinical pharmacology, 2020)
Keywords: modeling and simulation; PBPK; drug-drug interactions; pharmacokinetics and drug metabolism; clinical pharmacology (CPH); MIDD (model-informed drug development)