Bioequivalence and Bioavailability Forum • forced BE?

forced BE? [Design Issues]

posted by ElMaestro – Denmark, 2017-08-07 15:44 (2451 d 23:34 ago) – Posting: # 17668
Views: 15,126

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.

—
Pass or fail!
ElMaestro

Complete thread:

General BE topics VSL 2017-06-05 20:34 [Design Issues]
- General BE topics ElMaestro 2017-06-06 00:20
- General BE topics Helmut 2017-06-06 14:24
  - General BE topics VSL 2017-06-06 19:34
    - General BE topics DavidManteigas 2017-06-12 12:35
      - forced BE? Helmut 2017-08-04 15:51
        
        forced BE? DavidManteigas 2017-08-07 12:42
        
        forced BE? Helmut 2017-08-07 13:31
        
        forced BE?ElMaestro 2017-08-07 13:44
        
        forced BE? Helmut 2017-08-07 14:00
        
        forced BE? ElMaestro 2017-08-07 15:58
        
        forced BE? DavidManteigas 2017-08-07 14:02
        
        forced BE? Helmut 2017-08-07 14:26