Retention samples [Regulatives / Guidelines]

posted by priyanka12345 – India, 2018-05-09 17:57 (2149 d 18:09 ago) – Posting: # 18758
Views: 2,433

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.

Regards,
PRIYA


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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
69 visitors (0 registered, 69 guests [including 7 identified bots]).
Forum time: 11:07 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