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

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

posted by Helmut – Vienna, Austria, 2011-10-21 17:01 (5356 d 17:42 ago) – Posting: # 7529
Views: 18,817

Dear Outlaw Torn!

❝ 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)?

One product (=one study) was approved by the German BfArM June this year (submitted May 2010). Two other studies (different drug) were submitted in the meantime. All studies did not go into stage 2 and no α-adjustment was performed (according to the protocol: Potvin’s Method C, power >80; 90% confidence intervals).

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Helmut Schütz

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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 DesignsHelmut 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