Comparision of Dissolution profile [Dissolution / BCS / IVIVC]

posted by velupharm – 2006-07-31 11:16 (6913 d 02:51 ago) – Posting: # 191
Views: 4,653

Daer all
for US-FDA,when we do a biostudy with highest strength and asked for a biowaiver of lower strengths,should the dissolution proile be matched with corresponding doses of the innovator or within the different strengths of our own product or both the ways?

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,677 registered users;
83 visitors (0 registered, 83 guests [including 52 identified bots]).
Forum time: 14:08 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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