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

C Wagner; P Zhao; Y Pan; V Hsu; J Grillo; S M Huang; V Sinha

doi:10.1002/psp4.33

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

CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17.

Authors

C Wagner¹, P Zhao¹, Y Pan², V Hsu¹, J Grillo¹, S M Huang¹, V Sinha¹

Affiliations

¹ Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring Maryland, USA.
² Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, USA.

PMID: 26225246
PMCID: PMC4429576
DOI: 10.1002/psp4.33

Abstract

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.