Bioequivalence and Bioavailability Forum 09:21 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Neelu Singh
Junior

India,
2018-10-05 06:57

Posting: # 19409
Views: 424
 

 Retention of BA/BE samples [Regulatives / Guidelines]

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".
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,929 posts in 4,039 threads, 1,286 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

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