2020-09-06 17:43
(707 d 15:47 ago)

Posting: # 21909
Views: 1,575

 Retention for multicenter patient BABE study [Regulatives / Guidelines]

Dear all
As per the recently published usfda guidance "Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)"

For products manufactured in single-dose units, 30 units each of the test article and
reference standard from each shipment or, for products manufactured in multi-dose units, 3 units each of the test article and reference standard from each shipment, to conduct the necessary testing of the samples.

If we consider approx 20 clinical sites in patient BABE study, considering the guidance for single dose units 30 RLD required as retention quantity for each shipment.

20 sites x 30 single unit= 600 RLD.

The calculated quantity required is very high than the suggested in older guidance i.e. five times all of the release tests.

Is the new published guidance justifies the less requirement of retention quantity? :confused:

Edit: Guidance linked. [Helmut]

2020-09-14 14:21
(699 d 19:09 ago)

@ pash413
Posting: # 21919
Views: 1,056

 Retention for multicenter patient BABE study

This is how I will plan for retention samples. Maximum quantity of retention samples is 300 units (tablets or injections etc.).
  1. procure 300 units per manufacturing batch (for this reason better to keep to one lot)
  2. distribute portion of these 300 retentions samples to each center along with each shipment (again you are better off with one shipment though you have not much control)
  3. you ship required clinical IDP to each center and ask them to aliquot and keep the representative retention samples for test and reference products at each site. at the end of the study all clinical sites are expected to ship the retention samples for storage to the reminder of the required duration. Usually this would be at a CRO site equipped to store retention samples.

  4. Recently FDA published a guidance on retention samples, which gives a provision to request the FDA seeking waiver for keeping lesser quantity of retention samples (you better initiate such correspondence before the study start to avoid any surprises
“For products not included in Appendix 1, NDA and ANDA applicants or CROs should submit requests that FDA not take action if they wish to retain less than the quantity of reserve samples of the test product and reference standard used in BA or BE testing set forth in 21 CFR 320.38(c).”

Hope this helps.
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