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

posted by jag009  – NJ, 2019-10-24 20:54 (1068 d 19:34 ago) – Posting: # 20725
Views: 3,532

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

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