Retention samples [Regulatives / Guidelines]

posted by priyanka12345 – India, 2018-05-09 15:57 (1561 d 02:21 ago) – Posting: # 18758
Views: 2,193

Dear All

As per FDA guidance for industry on Handling and Retention of BA and BE Testing Samples
the following is stated.

Because the Agency has limited experience with the retention and testing of non-solid oral
dosage forms, the Agency is unable to recommend an upper limit for the retention of non-solid
oral dosage forms at this time.

Can any one please let me know how much quantity is required as reserve samples for suspension.


Edit: Guidance linked and subject line changed. Please don’t shout[Helmut]

Complete thread:

UA Flag
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 8 (1 registered, 7 guests [including 5 identified bots]).
Forum time: Wednesday 18:18 CEST (Europe/Vienna)

There is no point in being precise when you don’t know
what you’re talking about.    attributed to John Tukey

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