Different batches [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-03-07 16:10 (807 d 06:35 ago) – Posting: # 21222
Views: 3,114

(edited by wienui on 2020-03-07 17:56)

Hi All,

» In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns.

Why send a justification which is not needed?

It is nothing against to use a different batch's for different studies for the the same drug.

Best regards,

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
22,092 posts in 4,630 threads, 1,567 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 23:46 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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