Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-11 18:16 CET (UTC+1h)
 

forced BE? [Design Issues]

posted by ElMaestro - Denmark, 2017-08-07 13:44  - Posting: # 17668
Views: 1,576

Hi Hötzi,

» (blahblah) The basis of these estimates should also be given. It is important to investigate the sensitivity of the sample size estimate to a variety of deviations from these assumptions and this may be facilitated by providing a range of sample sizes appropriate for a reasonable range of deviations from assumptions. In confirmatory trials, assumptions should normally be based on published data or on the results of earlier trials.

Yessir!!!!!!!!
Thanks for bringing it up.

That is indeed why we need to apply more bootstrapping in BE.

It, too, tells what sample size we need, but in contrast to ordinary power calcs it allows one to take into account that residuals may not be normal even though the evaluation itself makes that assumption. And that is a story for another day.

I could be wrong, but…


Best regards,
ElMaestro

A potentially biased estimator may be a relevant estimator. The case of REML speaks volumes.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,550 Posts in 3,757 Threads, 1,089 registered users;
36 users online (0 registered, 36 guests).

To know much is often the cause of doubting more.    Michel de Montaigne

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