Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK: Physiologically Based Pharmacokinetic Modeling to Support Dose Selection

Wagner, C.; Zhao, P.; Pan, Y.; Hsu, V.; Grillo, J.; Huang, SM; Sinha, V.

doi:10.1002/psp4.33

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK: Physiologically Based Pharmacokinetic Modeling to Support Dose Selection

Journal Article · Wed Apr 01 00:00:00 EDT 2015 · CPT: Pharmacometrics & Systems Pharmacology

DOI:https://doi.org/10.1002/psp4.33· OSTI ID:1629923

Wagner, C. ^[1]; Zhao, P. ^[2]; Pan, Y. ^[3]; Hsu, V. ^[2]; Grillo, J. ^[2]; Huang, SM ^[2]; Sinha, V. ^[2]

US Food and Drug Administration, Silver Spring, MD (United States). Office of Clinical Pharmacology, Office of Translational Sciences; DOE/OSTI
US Food and Drug Administration, Silver Spring, MD (United States). Office of Clinical Pharmacology, Office of Translational Sciences
US Food and Drug Administration, Silver Spring, MD (United States). Office of Generic Drugs, Center for Drug Evaluation and Research

A workshop entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection” was hosted on March 10, 2014 by the US Food and Drug Administration (FDA) at its White Oak Campus in Silver Spring, MD.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 selection in specific patient populations. The conference benefited from strong and diverse participation from the FDA Center for Drug Evaluation and Research (CDER) leaders, European Medicine Agency (EMA) delegates, and pharmaceutical 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 applications 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 physiological 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 plenary presentations and panel session transcripts posted on the FDA’s website.

View Accepted Manuscript (DOE)

Research Organization:: Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)

Sponsoring Organization:: USDOE Office of Science (SC)

Grant/Contract Number:: SC0014664

OSTI ID:: 1629923

Journal Information:: CPT: Pharmacometrics & Systems Pharmacology, Journal Name: CPT: Pharmacometrics & Systems Pharmacology Journal Issue: 4 Vol. 4; ISSN 2163-8306

Publisher:: WileyCopyright Statement

Country of Publication:: United States

Language:: English

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