Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

Al Shoyaib, Abdullah; Riedmaier, Arian Emami; Kumar, Anita; Roy, Partha; Parrott, Neil John; Fang, Lanyan; Tampal, Nilufer; Yang, Yuching; Jereb, Rebeka; Zhao, Liang; Wu, Fang

doi:10.1002/psp4.12913

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

Journal Article · Mon Jan 02 23:00:00 EST 2023 · CPT: Pharmacometrics & Systems Pharmacology

DOI:https://doi.org/10.1002/psp4.12913· OSTI ID:2425786

Al Shoyaib, Abdullah ^[1]; Riedmaier, Arian Emami ^[2]; Kumar, Anita ^[3]; Roy, Partha ^[1]; Parrott, Neil John ^[4]; Fang, Lanyan ^[1]; Tampal, Nilufer ^[1]; Yang, Yuching ^[1]; ^[5]; Zhao, Liang ^[1]; Wu, Fang ^[1]

US Food and Drug Administration, Silver Spring, MD (United States)
Bristol Myers Squibb, Princeton, NJ (United States)
Amneal Pharmaceuticals, Bridgewater, NJ (United States)
Research Innovation Center Basel (Switzerland)
Sandoz Development Center (Slovenia)

This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches.” The US Food and Drug Administration in collaboration with the Center for Research on Complex Generics organized this workshop where this particular session titled “Oral PBPK for Evaluating the Impact of Food on BE” presented successful cases of PBPK modeling approaches for food effect assessment. Recently, PBPK modeling has started to gain popularity among academia, industries, and regulatory agencies for its potential utility during bioavailability (BA) and/or bioequivalence (BE) studies of new and generic drug products to assess the impact of food on BA/BE. Considering the promises of PBPK modeling in generic drug development, the aim of this workshop session was to facilitate knowledge sharing among academia, industries, and regulatory agencies to understand the knowledge gap and guide the path forward. This report collects and summarizes the information presented and discussed during this session to disseminate the information into a broader audience for further advancement in this area.

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:: 2425786

Journal Information:: CPT: Pharmacometrics & Systems Pharmacology, Journal Name: CPT: Pharmacometrics & Systems Pharmacology Journal Issue: 5 Vol. 12; ISSN 2163-8306

Publisher:: WileyCopyright Statement

Country of Publication:: United States

Language:: English

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