mindblowing [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-10-11 07:44 (2088 d 05:26 ago) – Posting: # 16714
Views: 11,700

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 :-):-):-)

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 9 (1 registered, 8 guests [including 5 identified bots]).
Forum time: Thursday 13:10 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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