Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: Report of an FDA public workshop on PBPK

  • Wagner C
  • Zhao P
  • Pan Y
 et al. 
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The US Food and Drug Administration (FDA) public workshop, entitled ''Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection'' focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions. 1 The workshop endeavored to (i) assess the current state of knowledge in the application of PBPK in regulatory decision-making, and (ii) share and discuss best practices in the use of PBPK modeling to inform dose selec-tion in specific patient populations. The conference benefited from strong and diverse participation from the FDA Center for Drug Evaluation and Research (CDER) leaders, Euro-pean Medicine Agency (EMA) delegates, and pharmaceuti-cal industry and academia representatives. The workshop commenced with plenary presentations by speakers from the FDA, industry, and academia. In the two panel sessions, detailed questions on the current status and future applica-tions of PBPK in drug development and regulatory decisions were discussed. An important focus of the dialog was the need to better define what constitutes a credible physiologi-cal system and the evidentiary standards needed for using such a system in making regulatory decisions. This report provides a content summary of the workshop, based on ple-nary presentations and panel session transcripts posted on the FDA's website. 2

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  • C. Wagner

  • P. Zhao

  • Y. Pan

  • V. Hsu

  • J. Grillo

  • S. M. Huang

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