Replicate Study design for Brazil [Regulatives / Guidelines]

posted by balakotu – India, 2018-05-21 15:31 (2604 d 22:51 ago) – Posting: # 18792
Views: 3,888

Dear All,

Brazil submission: Thus any body have any idea on Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil). If acceptable what is the acceptance criteria to be followed (USFDA/Europe Approach).

Regards
Kotu


Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,697 registered users;
90 visitors (0 registered, 90 guests [including 15 identified bots]).
Forum time: 14:22 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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