Nope [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2017-11-14 00:21  – Posting: # 17977
Views: 5,604

Hi ElMaestro,

» Best I can come up with is as follows:
» The only thing that determines the need for for stage 2 is the CV. :blahblah:
»
» So run the sims in the usual fashion, but add 5-20 points on the CV for the power and sample size estimation.

That’s not my point. Meditate over my example. We would initiate the second stage with 28 subjects (driven by the CV of Cmax 0.30) but should stop after the first stage for AUC (CV 0.20).

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,250 posts in 4,262 threads, 1,397 registered users;
online 17 (0 registered, 17 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 10:20 CET

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

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