Bioequivalence and Bioavailability Forum • Simulations

Simulations [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2013-12-05 16:51 (4218 d 07:55 ago) – Posting: # 12006
Views: 25,462

Hi Kumar,

❝ In my study CV is around 19% and sample size was 28 so can I use CV=20% and sample size stage 1(n1)=24 here as 28 is not there in the table.

❝ In second case upper limit of type 1 error rate is 0.05032 (exceeding 0.05),Is it means that here type 1 error inflation is present and regulator may reject the application.

I don’t understand what you want to achieve here. In 10⁶ simulations everything <0.05036 is not significantly >0.05. Potvin et al. covered the entire range of n₁ 12–60 and CV 10–100%. For Method B the largest inflation was 0.0485 and for Method C 0.0510. I would not step into this muddle unless I actually receive a deficiency letter. Did you?

Sometimes you get significant results. Why not? I simulated your CV 19% and n₁ 28. 10⁶ simulations each, Method C.

run   α_emp

 1  0.049872

 2  0.049777

 3  0.050218

 4  0.049988

 5  0.049882

 6  0.050440 *

 7  0.049946

 8  0.050084

 9  0.050139

10  0.050289

Now what?

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Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12
- 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
        
        Simulations Helmut 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
        
        SimulationsHelmut 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