Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

Abstract

AbstractOn November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long‐Acting Injectable and Implantable (LAI) Drug Products.” This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products. This report summerized presentations and panel discussions for topics including challenges and opportunities in development and assessment of generic LAI products, current status of utilizing MIE, recent research progress of utilizing MIE in generic LAI products, alternative designs for BE studies of LAI products, and model validation/verification strategies associated with different types of MIE approaches.