If method doesn't exist in FDA Disso Database [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2019-10-24 20:54  – Posting: # 20725
Views: 2,057

Hi,
Just want to get your 2 cents on this..
For ANDA, if the dissolution method for a drug product does not exist in the FDA dissolution database but exists in the USP dissolution database, the USP method is acceptable right?

We've done this before and never had issue from the FDA. Just want know if anyone has experienced push back before.

Thx
J

Complete thread:

Activity
 Admin contact
20,794 posts in 4,354 threads, 1,446 registered users;
online 18 (1 registered, 17 guests [including 9 identified bots]).
Forum time: 04:50 CEST (Europe/Vienna)

I’m not a pessimist,
I’m just a well informed optimist.    José Saramago

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