Retention [Regulatives / Guidelines]

posted by Vuas – India, 2021-03-05 19:02 (440 d 01:17 ago) – Posting: # 22248
Views: 1,856

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]

Complete thread:

UA Flag
Activity
 Admin contact
22,085 posts in 4,629 threads, 1,566 registered users;
online 16 (0 registered, 16 guests [including 10 identified bots]).
Forum time: Thursday 21:19 CEST (Europe/Vienna)

That which is not controversial
is of no particular interest.    Johann Wolfgang von Goethe

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