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

posted by ping4santosh  – India, 2020-03-12 19:18 (806 d 10:45 ago) – Posting: # 21260
Views: 2,296

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.

Cheers,
SKM

Complete thread:

UA Flag
Activity
 Admin contact
22,110 posts in 4,630 threads, 1,567 registered users;
online 9 (0 registered, 9 guests [including 9 identified bots]).
Forum time: Saturday 07:03 CEST (Europe/Vienna)

We can teach from our experience,
but we cannot teach experience.    Sasha Azevedo

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