Log in
Register|
jag009 ★★★ NJ, 2019-10-24 22:54 (1638 d 03:14 ago) Posting: # 20725 Views: 4,156 |
|
|
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 ★★★   Vienna, Austria, 2019-10-25 02:33 (1637 d 23:35 ago) @ jag009 Posting: # 20726 Views: 2,894 |
|
|
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).
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 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
![[image]](img/uploaded/image624.png)
![[image]](img/uploaded/image625.png)
|
jag009 ★★★ NJ, 2019-10-30 03:23 (1632 d 21:45 ago) @ Helmut Posting: # 20731 Views: 2,882 |
|
|
Thanks Helmut! J |
Ing. Helmut Schütz