Vuas
☆    

India,
2021-03-05 20:02
(1118 d 23:01 ago)

Posting: # 22248
Views: 2,337
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2021-03-09 14:38
(1115 d 04:25 ago)

@ Vuas
Posting: # 22252
Views: 1,964
 

 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.

To lift your mood: [image] The Suppository Song

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Vuas
☆    

India,
2021-03-10 10:46
(1114 d 08:18 ago)

@ Helmut
Posting: # 22255
Views: 1,977
 

 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]
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
72 visitors (0 registered, 72 guests [including 8 identified bots]).
Forum time: 19:04 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5