##  [Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA)](/index%2ephp/mandate/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new-drug-application-anda) 

May 26, 2026

The guidance details on below pointers:

1. 1. General BE Principles: Rate and extent of absorption should not show significant difference from listed drug at same molar dose under similar conditions.
2. 2. Study Design: Study populations (healthy vs. patients, age, sex), study types (single/multiple dose, crossover/parallel, replicate), sample size, fasting vs. fed conditions
3. 3. Replicate Design: Partial or fully replicate crossover for highly variable drugs or narrow therapeutic index drugs; uses fewer subjects than non-replicate.
4. 4. Fasting vs. Fed: Both fasting and fed BE studies recommended for all oral IR and MR products unless serious adverse events anticipated.
5. 5. Post-Approval Changes: Compare post-change product to RLD (not pre-change); in vitro comparison recommended generally.
6. 6. Study Population: Include similar male/female proportions; include subjects ≥60 years if drug for elderly; adult BE can support pediatric assessment.
7. 7. Other aspects like new dosage forms, handling outliers, etc.



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Source

[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequ…](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-abbreviated-new-drug?utm_medium=email&utm_source=govdelivery)

 

 

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