Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco Homepage – Campinas, SP, Brazil, 2020-03-08 00:32 (204 d 17:07 ago) – Posting: # 21224
Views: 2,472

Hi Osama,

» 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.

I agree with you. It was just a suggestion based on our previous experience in Brazil :-|. Sometimes we need to explain the inexplicable to health authority to avoid delays in the dossier review :-D


Complete thread:

 Admin contact
21,084 posts in 4,398 threads, 1,468 registered users;
online 5 (1 registered, 4 guests [including 2 identified bots]).
Forum time: Monday 18:40 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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