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

posted by ping4santosh  – India, 2020-03-12 18:18  – Posting: # 21260
Views: 1,355

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:

Activity
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 16 (1 registered, 15 guests [including 5 identified bots]).
Forum time: 08:08 UTC (Europe/Vienna)

In God we trust;
all others must bring data.    W. Edwards Deming

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