Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco Homepage – Campinas, SP, Brazil, 2020-03-06 13:37 (1056 d 09:04 ago) – Posting: # 21220
Views: 3,324

❝ 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
22,477 posts in 4,708 threads, 1,603 registered users;
22 visitors (0 registered, 22 guests [including 7 identified bots]).
Forum time: 22:42 CET (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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