dshah
★★  

India/United Kingdom,
2024-03-26 18:15
(82 d 11:28 ago)

Posting: # 23923
Views: 1,711
 

 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
(54 d 12:28 ago)

@ dshah
Posting: # 23963
Views: 1,052
 

 Handling and Retention of BA and BE Testing Samples

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
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