Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco Homepage – Campinas, SP, Brazil, 2020-03-06 13:37 (1004 d 03:16 ago) – Posting: # 21220
Views: 3,306

❝ Can we expect any query on authority or specific requirement, we need to met before study initiation.


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.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Marcelo Davanço

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
26 visitors (0 registered, 26 guests [including 7 identified bots]).
Forum time: 16:54 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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