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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
Author(s) -
Zhang Xinyuan,
Yang Yuching,
Grimstein Manuela,
Fan Jianghong,
Grillo Joseph A.,
Huang ShiewMei,
Zhu Hao,
Wang Yaning
Publication year - 2020
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.1767
Subject(s) - physiologically based pharmacokinetic modelling , food and drug administration , clinical pharmacology , medicine , regulatory science , pharmacology , drug , drug administration , pharmacokinetics , medical physics , management science , engineering , pathology
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.