Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2020-03-15 07:25 (836 d 09:19 ago) – Posting: # 21271
Views: 2,198

Hi,

» I know the US rules but not if it's the same as in India...
»
» Please let us know the US rules.

In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.


Thx
J

Complete thread:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Wednesday 17:45 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

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