Bioequivalence and Bioavailability Forum • two-stage design power 90% second stage

two-stage design power 90% second stage [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2012-08-02 13:54 (4707 d 05:44 ago) – Posting: # 9023
Views: 15,033

Hello Yvonne,

❝ or option c: simulations are relatively difficult but authorites will accept also sample size calculation in the second stage with 90% power (which I hope is the answer :-) ).

Yes, I think C is the right one here.
What I would do if I were you: Make a series of simulations that show that a target power of 0.9 adequately controls alpha at or below 0.05 under your conditions (do it for a good range of CV's and N1's) and show this documentation to regulators. A sc. advice is of course a good idea. They may ask for a copy of your software, e.g. to make sure it actually reproduces something known (like some of the values of Potvin 2008).

—
Pass or fail!
ElMaestro

Complete thread:

two-stage design power 90% second stage Yvonne 2012-08-02 09:50
- two-stage design power 90% second stage ElMaestro 2012-08-02 10:17
  - two-stage design power 90% second stage Yvonne 2012-08-02 11:47
    - two-stage design power 90% second stageElMaestro 2012-08-02 11:54
- two-stage design power 90% in sample size adaption d_labes 2012-08-02 10:33
  - two-stage design power 90% in sample size adaption ElMaestro 2012-08-02 11:29
    - two-stage design power 90% in sample size adaption Yvonne 2012-08-02 12:06
      - two-stage design power 90% in sample size adaption ElMaestro 2012-08-02 16:59
- Are simulations sufficient? …lenghty post! Helmut 2012-08-02 17:39
  - adjusted alpha = 0.045 d_labes 2012-08-03 11:33
    - adjusted alpha = 0.038 Helmut 2012-08-03 14:26
      - adjusted alpha by sims? d_labes 2012-08-03 15:48
        
        Yeah but, no but, yeah but, no but… Helmut 2012-08-03 16:39
        
        Yeah but, no but ... d_labes 2012-08-07 14:42
        
        Yeah but, no but ... Helmut 2012-08-07 15:14