Bioequivalence and Bioavailability Forum • Potvin’s 2-stage adaptive design

Potvin’s 2-stage adaptive design [Two-Stage / GS Designs]

posted by GSD – Canada, 2012-08-17 22:56 (4692 d 10:50 ago) – Posting: # 9076
Views: 23,619

Hey Everyone,

For Potvin’s 2-stage adaptive design, does anyone know how to simulate for the overall type I error with EMA reference scaling (Full Replicate)?

If there were no EMA reference scaling, then we can simulate random numbers from a normal distribution with mean centered on ln(0.8) to estimate the type I error. But what distribution should we simulate from to account for the random changing nature of the acceptance limits (EMA scaling)?

Thanks a lot in advance for the help :)

Complete thread:

Potvin’s 2-stage adaptive designGSD 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 complete Helmut 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