Bioequivalence and Bioavailability Forum • EMA: Two-Stage Sequential Designs

EMA: Two-Stage Sequential Designs [Two-Stage / GS Designs]

posted by d_labes – Berlin, Germany, 2010-06-15 18:02 (5485 d 13:58 ago) – Posting: # 5520
Views: 16,197

Dear Helmut, dear all!

I have heard some rumor that the Potvin design C may not accepted by the EMA.
Especially the unpenalized stop (without alpha spending) in the first stage if power was demonstrated >80%.

Any comments from the participants of the EGA meeting (aka Klagemauer)?

—
Regards,

Detlew

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 Designsd_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 yet The 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