Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-23 17:29 CEST (UTC+2h)

Retention samples [Regulatives / Guidelines]

posted by priyanka12345 - India, 2018-05-09 15:57  - Posting: # 18758
Views: 531

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 15 (0 registered, 15 guests [including 13 identified bots]).

[The] impatience with ambiguity can be criticized in the phrase:
absence of evidence is not evidence of absence.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed