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USFDA Guidance: Statistical Approaches to Establishing Bioequivalence

Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance "Statistical Approaches to Establishing Bioequivalence".

The purpose of this guidance is to provide recommendations to sponsors and applicants planning to analyze in vitro or in vivo BE studies for INDs, NDAs, ANDAs, and supplements.


There are several statistical approaches that can be used for BE comparisons, and this guide explains how to utilize them both generally and in specific situations. According to FDA, this guidance will assist applicants with planning and analyzing BE studies in order to minimize the number of approval cycles.


The guidance also covers topics such as missing data and interrelated events, adaptive designs, and specific situations, such as narrow therapeutic index drugs and drugs with high variability.


This guidance discusses general approaches that can also be applied in clinical pharmacology studies and other similar settings to assess pharmaceutical equivalence and is intended to encourage the use of science-based approaches to making statistical BE assessments.


Click this LINK to know more about the general considerations and specific situations mentioned in this guidance.



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