CPT: Pharmacometrics & Systems Pharmacology (May 2023)

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

  • Andrew Babiskin,
  • Fang Wu,
  • Youssef Mousa,
  • Ming‐Liang Tan,
  • Eleftheria Tsakalozou,
  • Ross L. Walenga,
  • Miyoung Yoon,
  • Sam G. Raney,
  • James E. Polli,
  • Anna Schwendeman,
  • Vishalakshi Krishnan,
  • Lanyan Fang,
  • Liang Zhao

DOI
https://doi.org/10.1002/psp4.12920
Journal volume & issue
Vol. 12, no. 5
pp. 619 – 623

Abstract

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Abstract On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches.” The overall aims of the workshop included (i) engaging the generic drug industry and other involved stakeholders regarding how mechanistic modeling and simulation can support their product development and regulatory submissions; (ii) sharing the current state of mechanistic modeling for bioequivalence (BE) assessment through case studies; (iii) establishing a consensus on best practices for using mechanistic modeling approaches, such as physiologically based pharmacokinetic modeling and computational fluid dynamics modeling, for BE assessment; and (iv) introducing the concept of a Model Master File to improve model sharing between model developers, industry, and the FDA. More than 1500 people registered for the workshop. Based on a postworkshop survey, the majority of participants reported that their fundamental scientific understanding of mechanistic models was enhanced, there was greater consensus on model validation and verification, and regulatory expectations for mechanistic modeling submitted in abbreviated new drug applications were clarified by the workshop.