BCS waiver [Dissolution / BCS / IVIVC]

posted by meghalvakil20 – 2016-04-28 01:04 (3355 d 22:21 ago) – Posting: # 16253
Views: 7,726

Is there a way we can find out if the generic drug application approved by FDA had submitted BCS waiver for any of the strengths and found to be bioequivalent for example Capecitatine. there are 3 generics approved by US FDA and 2 approval letters posted but how do we know if it was submitted with a BCS waiver and was approved.


Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,682 registered users;
21 visitors (0 registered, 21 guests [including 5 identified bots]).
Forum time: 23:25 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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