Different batches [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-03-08 10:19 (844 d 00:58 ago) – Posting: # 21225
Views: 3,013

Hi Marcelo,

» 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

The use of a different batch in the fed study as asked above from taiyab.jameel could be better as you can prove batches therpeutic equivalence consistency via in vivo studies.

On the contrary, in the case of additional strength biowaiver, it is a must to use the same biobatch for which the therpeutic equivalence was proven before via in vivo BE study.

Best regards,

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 9 (1 registered, 8 guests [including 2 identified bots]).
Forum time: Thursday 12:17 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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