Bioequivalence and Bioavailability Forum • Simulations

Simulations [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2013-12-05 17:55 (4217 d 22:50 ago) – Posting: # 12008
Views: 25,353

Hi Kumar,

❝ actually we have not yet submitted the report to the regulatory but our client wants clarification that how we are going to address the defiency 2 in the presentation thats all.

Maybe you will not receive a deficiency letter. :-D

In the meantime I succeeded with other studies (Method C; Germany, Austria, Denmark, Sweden, The Netherlands, Spain)…

If you want to be prepared:

Try Method B (94.12% CI in the first stage). Seems to be preferred by some European regulators.
Try Bonferroni’s correction (95% CI). Most conservative, IMHO.
Believe in my simulations. If you prefer higher numbers: 20·10⁶ sim’s, α_emp 0.050032 (ns >0.05, limit 0.05008).
Run your own.
Find someone how can do it for you (e.g., Detlew, ElMaestro, Vangelis, myself).

—
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Helmut Schütz

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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
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        SimulationsHelmut 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