jag009
★★★

NJ,
2019-10-24 20:54

Posting: # 20725
Views: 285
 

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

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
Helmut
★★★
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Vienna, Austria,
2019-10-25 00:33

@ jag009
Posting: # 20726
Views: 254
 

 USP should be fine

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).

[image]

[image]


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.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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jag009
★★★

NJ,
2019-10-30 02:23

@ Helmut
Posting: # 20731
Views: 142
 

 USP should be fine

Thanks Helmut!
J
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