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

dshah
★★

India,
2024-03-26 18:15
(250 d 00:55 ago)

Posting: # 23923
Views: 2,830

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

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

Achievwin ★★ US, 2024-04-23 18:16 (222 d 01:55 ago) @ dshah Posting: # 23963 Views: 1,906	Handling and Retention of BA and BE Testing Samples Post reply
	Can someone throw light on how to compute number of retention samples needed for a multi center patient trial. Is it N=30/center/shipment (some centers may recruit one or 2 patients) or N=30/batch/shipment to CRO and CRO will uniformly distribute across different centers based on the recruitment rate. We have to be mindful some RLDs are cost prohibitive e.g. 1 pre-filled syringe can be $ 8000