USP should be fine [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2019-10-25 00:33 (293 d 10:52 ago) – Posting: # 20726
Views: 1,281

Hi John,

» 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?

Yep.

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

Two slides of Malcolm Ross (Athens, last November).

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However, commonly it is the other way ’round. The USP adds methods once they are published in an NDA or ANDA. Malcolm has decades of experience with the FDA… I’ll meet him again in two weeks. Will ask whether he is aware of any problems.

Dif-tor heh smusma 🖖
Helmut Schütz
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