Generic submission in India [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-11-11 21:43  – Posting: # 20785
Views: 2,228

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
20,255 posts in 4,263 threads, 1,398 registered users;
online 10 (0 registered, 10 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 12:11 CET

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

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