Meets primary objective but not secondary objective [Study As­sess­ment]

posted by Achievwin – US, 2020-03-31 21:09 (479 d 19:53 ago) – Posting: # 21310
Views: 1,279

As far as Bioequivalence study is concerned there is only a primary objective (no secondary objectives) which is specified in the published BE guidance (in case of FDA), BE acceptance criteria is specified by Regulatory bodies per product. In the absence of a published guidance use the following criteria

1. Fasted and Fed studies
2. BE criteria must be met for 1) Parent drug (unless is not detected) and major circulating active metabolite (it needs to be more than 20% of the parent drug or so),
3. establishing BE for inactive metabolites if they are not major circulating metabolites is only a supportive data)

Hope this helps.

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time: Saturday 17:03 CEST (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

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