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,
ElMaestro

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

Complete thread:

Activity
 Admin contact
20,815 posts in 4,356 threads, 1,447 registered users;
online 26 (1 registered, 25 guests [including 14 identified bots]).
Forum time: 12:51 CEST (Europe/Vienna)

Repetition does not transform a lie into a truth.    Franklin D. Roosevelt

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