Bioequivalence and Bioavailability Forum • Two stage BE design

Two stage BE design [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2013-10-17 19:28 (4267 d 01:52 ago) – Posting: # 11679
Views: 26,500

Hi Kumarnaidu,

❝ Can anybody tell me for using group sequential design which method (Potvin's C or B) should be used for EMEA.

I am receiving a lot of noise on the transmission frequencies that EU regulators are using. Sc. advice that I have experienced include the following feedback:

"You must use Potvin B."
"You must use Potvin C."
"You must use PROC GLM and not Potvin B" (luckily I had some Schützomycin tablets in my pocket and immediately swallowed a handfull. Otherwise the meeting could have ended with a mental breakdown or with a manslaughter.)

I think method B is the current EU winner due to alpha=0.0294 being used at both steps.

—
Pass or fail!
ElMaestro

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 designElMaestro 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
        
        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