Retention of BA/BE samples [Regulatives / Guidelines]

posted by Neelu Singh – India, 2018-10-05 08:57 (2118 d 06:54 ago) – Posting: # 19409
Views: 2,008

Dear All,
My Question is:

Please provide clarification related to retention of BABE samples. Is it compulsory to retain pilot study samples or only retention of pivotal study samples are sufficient in order to follow the retention criteria?

Reference:
1. As per CDSCO guideline "samples used in BA/BE study should be retained by organisation".
2. As per 21 CFR Sec. 320.38 Retention of bioavailability samples "retain an appropriately identified reserve sample of the drug product for which the applicant is seeking approval".

Complete thread:

UA Flag
Activity
 Admin contact
23,117 posts in 4,859 threads, 1,647 registered users;
35 visitors (0 registered, 35 guests [including 6 identified bots]).
Forum time: 15:52 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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