Biowaivers [Dissolution / BCS / IVIVC]

posted by Susan – 2007-10-25 23:42 (6021 d 06:31 ago) – Posting: # 1255
Views: 3,375

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

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,654 registered users;
98 visitors (0 registered, 98 guests [including 4 identified bots]).
Forum time: 06:13 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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