US FDA: Handling and Retention of Bioavailability (BA) and Bioequivalence (BE) Testing Samples

The draft guidance document “Handling and Retention of Bioavailability and Bioequivalence Testing Samples” is being distributed at March 2024

The guidance is intended to provide recommendations for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), clinical investigators, and independent third parties regarding the procedure for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, as required by 21 CFR 320.38 and 320.63.

The guidance highlights

1. how the test article and reference standard for BA and BE studies should be distributed to the testing facilities,
2. how testing facilities should randomly select samples for testing and material to maintain as reserve samples,
3. how the reserve samples should be retained
4. addresses the requirement at 21 CFR 320.38 (c) to retain sufficient quantity of reserve samples to allow FDA to perform five times all the release tests required in an application or supplemental application
5. describes the conditions under which the Agency does not generally intend to take enforcement action against an applicant or CRO for retaining less than the quantity of reserve samples of the test article and reference standard that were used in the BA or BE study as specified in 21 CFR 320.38(c)

The guidance also clarifies the points addressed in §§ 320.38 and 320.63.

SOURCES:

https://www.fda.gov/media/71393/download