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

posted by ping4santosh  – India, 2020-03-12 20:18 (1446 d 20:45 ago) – Posting: # 21260
Views: 2,829

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
22,912 posts in 4,806 threads, 1,636 registered users;
31 visitors (0 registered, 31 guests [including 8 identified bots]).
Forum time: 17:03 CET (Europe/Vienna)

It is the peculiar and perpetual error of the human understanding
to be more moved and excited by affirmatives than negatives.    Francis Bacon

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