Nope [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2017-11-14 01:21 (2326 d 10:50 ago) – Posting: # 17977
Views: 8,661

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).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
91 visitors (1 registered, 90 guests [including 7 identified bots]).
Forum time: 12:11 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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