mindblowing [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-10-11 09:44 (2726 d 00:06 ago) – Posting: # 16714
Views: 12,471

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
22,957 posts in 4,819 threads, 1,636 registered users;
95 visitors (0 registered, 95 guests [including 4 identified bots]).
Forum time: 08:51 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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