Meets primary objective but not secondary objective [Study As­sess­ment]

posted by Brus – Spain, 2020-03-27 17:22 (668 d 18:48 ago) – Posting: # 21303
Views: 2,039

Dear colleagues,

I tell them my case if they can help me:

We have carried out a bioequivalence study with a drug that, due to its metabolism, it generates various metabolites in the human body. In the protocol, we specified bioequivalence in one metabolite as the primary objective, and bioequivalence of two other different metabolites as a secondary objective.

What happens if we meet the primary objective but not the secondary one?

Thank you very much

Complete thread:

Activity
 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 8 (0 registered, 8 guests [including 8 identified bots]).
Forum time: Tuesday 12:10 CET (Europe/Vienna)

I love deadlines.
I love the whooshing sound they make
as they go by.    Douglas Adams

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