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

posted by jag009  – NJ, 2019-10-24 18:54 (400 d 04:15 ago) – Posting: # 20725
Views: 2,512

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
21,214 posts in 4,427 threads, 1,482 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: Friday 23:09 UTC (Europe/Vienna)

Science may be described as the art of systematic over-simplification –
the art of discerning what we may with advantage omit.    Karl R. Popper

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