GMR, theta 0 and that all [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2017-03-09 08:21  – Posting: # 17144
Views: 9,338

Dear Silva,

» What is the meaning of "True ratio of T/R for simulating" and what is the difference for GMR?

To obtain a value of the type 1 error or the power via simulations one has to create data for many studies, say 1 Mio, perform the TSD framework (using GMR=0.95 f.i., the A in Helmut's schemes above) on that data and count all studies in which BE was decided.

To create the study data you use the "True ratio of T/R" and the "True CV" and the statistical distributions relating these parameters to the observed outcomes of a study.

True ratio = 1.25 will create studies which are under the Null hypothesis "bioinequivalence" and counting studies which decide here nevertheless BE gives you the type I error "Null hypothesis true but decided as false".

Hope this was understandable.



Complete thread:

 Admin contact
20,138 posts in 4,246 threads, 1,386 registered users;
online 11 (0 registered, 11 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 06:55 UTC

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

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