Retention [Regulatives / Guidelines]

posted by Vuas – India, 2021-03-05 20:02 (813 d 23:42 ago) – Posting: # 22248
Views: 2,096

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
22,614 posts in 4,740 threads, 1,609 registered users;
15 visitors (1 registered, 14 guests [including 7 identified bots]).
Forum time: 20:45 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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