Generic submission in India [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-11 21:43 (715 d 14:15 ago) – Posting: # 20785
Views: 3,519

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
21,758 posts in 4,550 threads, 1,545 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Wednesday 12:59 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

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