Bioequivalence and Bioavailability Forum 04:45 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Nope [Two-Stage / GS Designs]

posted by Helmut Homepage - Vienna, Austria, 2017-11-14 00:21  - Posting: # 17977
Views: 3,306

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,939 posts in 4,040 threads, 1,288 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed