Statistical Approaches to Establishing Bioequivalence

The guidance details on below pointers:

1. 1. BE Approaches: Discusses average bioequivalence (ABE), population bioequivalence (PBE), and individual bioequivalence (IBE) approaches.
2. 2. Application Scope: In vivo and in vitro BE studies for INDs, NDAs, ANDAs, and supplements
3. 3. Replaces 1999 Draft: Replaces 1999 draft guidance ""Average, Population, and Individual Approaches to Establishing Bioequivalence""
4. 4. Updated Topics (2022): Missing data and intercurrent events, adaptive design, narrow therapeutic index drugs, highly variable drugs.
5. 5. Missing Data: Outlines ICH estimands concept; advises methods to minimize missing data to avoid bias, loss of precision/power.
6. 6. Other aspects include novel methodologies, highly variable drug products, etc.