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

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

posted by The Outlaw Torn – Europe, 2011-10-20 12:30 (5358 d 08:51 ago) – Posting: # 7524
Views: 18,410

Hi Helmut,

Do you have any updates to share about these submissions?

Has any authority commented on the lack of a penalty in stage one in case of successful conclusion (BE obtained)?

Any wisdom you can part with would be greatly appreciated.

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 DesignsThe 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