mindblowing [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2016-10-11 07:44  – Posting: # 16714
Views: 10,707

I think I overlooked this:

This was a two stage, four period, cross-over, block randomized, replicate design, single dose bioavailability study in healthy volunteers without charcoal blockade. Forty-eight healthy volunteers (24 males and 24 females, aged 18-55 years) were enrolled in the first stage according to study protocol.
Bioequivalence was reached at the first stage according to protocol; therefore the second stage of the study was not required to be performed. There were four periods in the first stage: both test and reference product were given twice according to a replicated design.

Alpha 2.94%. Approved in Germany, Sweden, Portugal, Iceland, Hungary, Italy, 2015 :-):-):-)

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

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