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RegisterUSP should be fine [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2019-10-25 02:33 (1250 d 15:38 ago) – Posting: # 20726
Views: 2,448
Hi John,
Yep.
Two slides of Malcolm Ross (Athens, last November).
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.
❝ 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).
![[image]](img/uploaded/image624.png)
![[image]](img/uploaded/image625.png)
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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- If method doesn't exist in FDA Disso Database jag009 2019-10-24 20:54 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- USP should be fineHelmut 2019-10-25 00:33
- USP should be fine jag009 2019-10-30 02:23
- USP should be fineHelmut 2019-10-25 00:33
Ing. Helmut Schütz