This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted.

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.