Meets primary objective but not secondary objective [Study As­sess­ment]

posted by Brus – Spain, 2020-03-27 17:22 (387 d 16:58 ago) – Posting: # 21303
Views: 1,653

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

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