Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-22 10:23 CET (UTC+1h)
 

Nope [Two-Stage / GS Designs]

posted by Helmut Homepage - Vienna, Austria, 2017-11-14 00:21  - Posting: # 17977
Views: 336

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).

[image]Regards,
Helmut Schütz 
[image]

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,494 Posts in 3,746 Threads, 1,086 registered users;
34 users online (0 registered, 34 guests).

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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