Generic submission in India [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-11 21:43 (431 d 00:45 ago) – Posting: # 20785
Views: 3,306

Hi folks,

Can someone direct me to guidance doc(s) for generic submission in India? I would like to get some info on the comparative dissolution testing (is it like FDA where one has to carry out a recommended disso?), potency differences? I got the BE reqts part.

Thx
J

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Friday 22:29 CET (Europe/Vienna)

Statistics is the grammar of science.    Karl Pearson

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