Biowaiver [Dissolution / BCS / IVIVC]

posted by John Gray – 2008-06-19 08:36 (6572 d 22:57 ago) – Posting: # 1949
Views: 5,845
(edited on 2008-06-19 09:38)

You get a biowaiver if the ratio of the excipeints to the total weight of dosage forms are within the limits as per supac-IR or supac-MR (if urs is a extended release) upto level-1 and level-2.

--
Edit: Full quote removed. Please see this post! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
169 visitors (0 registered, 169 guests [including 23 identified bots]).
Forum time: 07:34 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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