Replicate Study design for Brazil [Regulatives / Guidelines]

posted by balakotu – India, 2018-05-21 13:31  – Posting: # 18792
Views: 935

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:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,271 posts in 4,099 threads, 1,315 registered users;
online 14 (1 registered, 13 guests [including 9 identified bots]).

It’s easy to lie with statistics;
it is easier to lie without them.    Frederick Mosteller

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5