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

posted by jag009  – NJ, 2020-03-13 16:34 (314 d 20:12 ago) – Posting: # 21268
Views: 1,735

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
21,310 posts in 4,445 threads, 1,489 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Friday 12:47 UTC (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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