Meets primary objective but not secondary objective [Study As­sess­ment]

posted by Achievwin – US, 2020-03-31 21:09 (543 d 10:45 ago) – Posting: # 21310
Views: 1,360

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
21,700 posts in 4,538 threads, 1,542 registered users;
online 8 (1 registered, 7 guests [including 3 identified bots]).
Forum time: Sunday 07:55 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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