FDA Updated Guidance on Statistical Approaches to Establishing Bioequivalence

Table of Contents
Regulatory Developments
March 2023


By Gail McGrew, Science Writer

FDA updated guidance on Statistical Approaches to Establishing Bioequivalence, published during December 2022, updates the requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. It provides definitions of BA and BE, and the types of in vitro and in vivo studies that are appropriate to measure BA and establish BE are set forth in part 320 (21 CFR part 320) in the guidance.