Vuas
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India,
2021-03-05 19:02
(480 d 23:01 ago)

Posting: # 22248
Views: 1,922
 

 Retention [Regulatives / Guidelines]

Hi everyone,
Some dosage forms like buccal tablets, rectal suppositories are not listed in Table -1 and 2 of Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c). However as per note:11, can we proceed for minimum sample retention quantity of 30 units each for test and reference products? Thanks in advance


Edit: Guidance linked. [Helmut]
Helmut
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Vienna, Austria,
2021-03-09 13:38
(477 d 04:25 ago)

@ Vuas
Posting: # 22252
Views: 1,610
 

 Retention

Hi Vuas,

» … can we proceed for minimum sample retention quantity of 30 units each for test and reference products?

See lines 63–65:

21 CFR 320.38(c) requires that applicants retain reserve samples of the test product and reference standard used in a BA or BE study that consist of a sufficient quantity to perform five times all the release tests required in the application or supplemental application.

(my emphasis)
If your test requires six units, 30 are fine. See also the guidance Handling and Retention of BA and BE Testing Samples.

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Vuas
☆    

India,
2021-03-10 09:46
(476 d 08:18 ago)

@ Helmut
Posting: # 22255
Views: 1,605
 

 Retention

» See lines 63–65:

21 CFR 320.38(c) requires that applicants retain reserve samples of the test product and reference standard used in a BA or BE study that consist of a sufficient quantity to perform five times all the release tests required in the application or supplemental application.

(my emphasis)
» If your test requires six units, 30 are fine. See also the guidance Handling and Retention of BA and BE Testing Samples.

Many thanks for response.
But for vaginal suppositories retention is given 30 units so we did studies with retention of 30 for rectal suppositories as well.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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