Bioequivalence and Bioavailability Forum • Got it. Ages for sims to complete

Got it. Ages for sims to complete [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2012-09-05 15:35 (4673 d 17:05 ago) – Posting: # 9151
Views: 21,419

Dear Detlew!

❝ This is not a surprise if you think twice.

❝ To have an empirical alpha IMHO it is indeed necessary to simulate studies at an GMR which is identical with the widened acceptance limits dependent on the CV used for the simulation.

❝ This is irrespective of the fact that we use the sample CV for widening the BE limits in the evaluation of each study. In simulating with a certain CV we know it and therefore we know also the inequivalence margins that would apply for the population.

Oh yes, you are right. But IMHO this is a true show-stopper (aka end of story) unless one has a super-computer in the backyard. Even if we use just 10⁴ sim’s in the sample size estimation that would mean 10¹⁰ sim’s for each point of the grid. BTW, even that would only work without intermediate power.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Potvin’s 2-stage adaptive design GSD 2012-08-17 20:56 [Two-Stage / GS Designs]
- Potvin’s 2-stage adaptive design + RSABE/ABEL Helmut 2012-08-18 00:39
  - Potvin’s 2-stage adaptive design + RSABE/ABEL GSD 2012-08-31 16:30
    - Tough job Helmut 2012-08-31 18:37
      - Tough job GSD 2012-08-31 19:23
        
        C/D for EMA? Good luck! Helmut 2012-09-01 15:09
      - Surprise? d_labes 2012-09-05 12:57
        
        Got it. Ages for sims to completeHelmut 2012-09-05 13:35
        
        Life belt d_labes 2012-09-05 14:51
        
        Life belt Helmut 2012-09-05 15:20
  - Power for Two stage Design K2K 2013-10-07 14:43
    - Power for Two stage Design Helmut 2013-10-07 14:59
      - Power for Two stage Design K2K 2013-10-08 14:35
        
        “Interim power” Helmut 2013-10-08 14:58
        
        “Interim power” K2K 2013-10-09 12:39
        
        Validation of PowerTOST Helmut 2013-10-09 14:10
        Phoenix/WinNonlin - power d_labes 2013-10-09 16:11
        
        Phoenix/WinNonlin - power Helmut 2013-10-09 18:19
        
        power K2K 2013-10-10 08:36