Bioequivalence and Bioavailability Forum • Handling and Retention of BA and BE Testing Samples

Handling and Retention of BA and BE Testing Samples [BE/BA News]

posted by dshah – India, 2024-03-26 18:15 (294 d 08:12 ago) – Posting: # 23923
Views: 3,043

Hi All!

FDA had published the draft guideline on: Handling and Retention of BA and BE Testing Samples.

The guidance highlights:

how the test article (T) and reference standard (RS) for BA and BE studies should be distributed to the testing sites,
how testing sites should randomly select samples for testing and material to maintain as reserve samples,
how the reserve samples should be retained,
and clarifying recommendations related to certain other relevant requirements.
The guidance updates:
the agency’s expectations for study sponsors and/or drug manufacturers, CROs, SMOs, and clinical investigators around the handling and retention of BA and BE testing samples
and the agency’s previously issued Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) guidance (August 2020) to further reduce the quantity of reserve samples to be retained. This updated compliance policy is for immediate implementation.

Regards,
Divyen

Handling and Retention of BA and BE Testing Samplesdshah 2024-03-26 17:15 [BE/BA News]
- Handling and Retention of BA and BE Testing Samples Achievwin 2024-04-23 16:16