Bioequivalence and Bioavailability Forum • Simulations

Simulations [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2013-10-22 15:20 (4262 d 09:14 ago) – Posting: # 11726
Views: 26,181

Hi Kumar,

❝ can you please guide me how you have calculated the power above so that from next time I can do this exercise for two stage design.

My simulations were done in R using package PowerTOST. Set up the framework (decision scheme, alphas in both stages, acceptance rule) and generate N BE-studies of n₁ sample sizes with the expected CV. For Potvin use a T/R-ratio of 1.25 (for alpha) or 0.95 (for power). Simulate N=10⁶ studies for alpha (slow convergence) and at least N=10⁵ studies for power. Number of studies passing / N at 1.25 = empiric alpha and at 0.95 = empiric power.
Depending on your CPU and programming skills expect run-times of 15 seconds up to one day for 10⁶ sim’s. :-D

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Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12 [Two-Stage / GS Designs]
- Two stage BE design ElMaestro 2013-08-06 10:05
- Two stage BE design Helmut 2013-08-06 15:31
  - Two stage BE design Mahesh 2013-08-07 06:51
    - Two stage BE design kumarnaidu 2013-10-17 15:08
      - Two stage BE design ElMaestro 2013-10-17 17:28
        
        Two stage BE design kumarnaidu 2013-10-18 05:59
        
        EMA vs. rest of the world Helmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our head Shuanghe 2013-10-18 10:05
        
        Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
        
        Change in statistical design kumarnaidu 2013-10-19 07:52
        
        Bad idea Helmut 2013-10-19 15:04
        
        Bad idea kumarnaidu 2013-10-21 06:01
        
        Change to Method B? Helmut 2013-10-21 14:51
        
        Change to Method B? kumarnaidu 2013-10-22 06:15
        
        SimulationsHelmut 2013-10-22 13:20
        
        Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
        
        Reach for the stars Helmut 2013-10-22 13:05
        
        Alpha inflation in two stage design kumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letters kumarnaidu 2013-12-05 06:18
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        Simulations Helmut 2013-12-05 16:55
        
        Simulations kumarnaidu 2013-12-06 06:07
        
        Ejaculatio praecox Helmut 2013-12-06 14:30
        
        Ejaculatio praecox kumarnaidu 2013-12-06 15:13
        
        All effects fixed Helmut 2013-12-06 15:31
        
        All effects fixed kumarnaidu 2013-12-09 07:33
        
        EMA… Helmut 2013-12-09 12:45