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

posted by jag009  – NJ, 2020-03-12 15:41 (310 d 02:41 ago) – Posting: # 21259
Views: 3,704

Hi everyone,

I have question relating to ANDA in India (CDSCO). With US ANDA, we have the FDA recommended dissolution method for a marketed drug which the generic company needs to carry out the Test vs Ref in-vitro with (if the method is not doable for some reason then the company must justify they have to use another meothod). Does this exist in India? If not then, what's the approach for India ANDA (I mean aside from developing your own method for your product and compare against the ref).

Reference article link, if available, would be greatly appreciated.


Complete thread:

 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Saturday 18:23 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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