Susan
●    

2007-10-25 23:42
(6823 d 18:05 ago)

Posting: # 1255
Views: 4,571
 

 Biowaivers [Dissolution / BCS / IVIVC]

Post reply
I am seeking clarification from experts on this 'BABE Forum' re. biowaivers.

In respect to an ANDA for a BCS Class I drug, is it possible to obtain a biowaiver without having to perform an initial full scale in vivo BE study? Or, as is my understanding, is a biowaiver only a possibility in subsequent (e.g. post SUPAC) applications?

Thanks,
Susan
 
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
178 visitors (0 registered, 178 guests [including 11 identified bots]).
Forum time: 17:48 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5