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

posted by jag009  – NJ, 2019-10-24 18:54  – Posting: # 20725
Views: 1,283

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
20,343 posts in 4,272 threads, 1,401 registered users;
online 4 (1 registered, 3 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 03:35 UTC

That which is static and repetitive is boring.
That which is dynamic and random is confusing.
In between lies art.    John Locke

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