BE demonstrated in pilot study [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2011-04-10 20:13 (5560 d 06:44 ago) – Posting: # 6882
Views: 3,552

Hi,

❝ I would appreciate your opinion on the case when bioequivalence is demonstrated in 12 subjects in Pilot BE Study and the stop criterion is specified in the Study Protocol prospectively.


it sounds to me like BE is demonstrated.
I would submit it.
—
Pass or fail!
ElMaestro

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