Bioequivalence and Bioavailability Forum • PAR not yet

PAR not yet [Two-Stage / GS Designs]

posted by The Outlaw Torn – Europe, 2011-10-27 13:07 (4986 d 10:33 ago) – Posting: # 7551
Views: 15,926

Hello all,

We provided our protocol to a central European country and this is what they responded about Potvin method C:

“Method C” as proposed in this publication is not acceptable, as type I error is not controlled on the 5% level and alternative methods securing type I error control are available.

They go on to suggest method B because "The authors demonstrate by simulations that the power of this method is only slightly lower than for “Method C”, resulting in comparable mean total number of subjects."

Any comments?

Thanks.

Complete thread:

Two-Stage Sequential Designs Helmut 2010-05-20 16:53 [Two-Stage / GS Designs]
- Two-Stage Sequential Designs yjlee168 2010-05-20 21:28
  - Two-Stage Sequential Designs Helmut 2010-05-21 01:06
    - EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
      - EMA: Two-Stage Sequential Designs Helmut 2010-06-15 16:23
        
        EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
        
        EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
        
        PAR? ElMaestro 2011-10-21 15:23
        
        PAR not yet Helmut 2011-10-21 16:02
        
        PAR not yet The Outlaw Torn 2011-10-25 08:57
        
        PAR not yetThe Outlaw Torn 2011-10-27 11:07
        
        Potvin C not acceptable! d_labes 2011-10-27 13:16
        PAR not yet ElMaestro 2011-10-27 13:25
        
        PAR not yet The Outlaw Torn 2011-10-31 07:45
        
        No (?) comment :-( Helmut 2011-10-31 15:04