If the reference product does not pass in BCS ?? [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2018-01-08 20:59 (2739 d 06:42 ago) – Posting: # 18150
Views: 5,450

How can I proceed with a biowaiver if the reference product does not pass in all conditions of dissolution required to BCS?

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,687 registered users;
67 visitors (0 registered, 67 guests [including 20 identified bots]).
Forum time: 04:42 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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