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

posted by ping4santosh  – India, 2020-03-12 19:18 (200 d 17:42 ago) – Posting: # 21260
Views: 1,642

Hi jag009,

AFAIK, it's upto the company to develop the disso profile and submit the data with acceptable range of F values.

If I have time over weekend, I will try to find references.


Complete thread:

 Admin contact
21,086 posts in 4,398 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 14:00 CEST (Europe/Vienna)

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

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