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

posted by jag009  – NJ, 2020-03-13 17:34 2601:5c5:8303:4970:8d4b:2511:d85d:afe0 – Posting: # 21268
Views: 932

Thank you ping4santosh. Lastly, is there a requirment on what kind of testings need to be done on the reference product (i.e, potenty or total assay, any others)? I know the US rules but not if it's the same as in India.

Thanks
J

Complete thread:

Activity
 Admin contact
20,459 posts in 4,296 threads, 1,414 registered users;
online 7 (0 registered, 7 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 21:30 CEST

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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