Bioequivalence and Bioavailability Forum • PAR not yet

PAR not yet [Two-Stage / GS Designs]

posted by The Outlaw Torn – Europe, 2011-10-25 10:57 (4559 d 15:11 ago) – Posting: # 7541
Views: 13,592

Hi Helmut,

Sorry for the delay (CPhI stuff) and thanks for the info.

We are involved in a project in which the CRO has proposed this study approach. My feedback was basically the same or similar (would I be ostracized if I said "essentially similar"?) to yours—as long as the consumer risk is preserved, I don't see why it wouldn't be okay to stop without penalty after the first stage if the BE study is successful (Potvin method C).

I'll make sure the CRO provides adequate justification in the protocol. Thanks for the feedback. If I get feedback from the authorities on this approach later on, I'll pass it on.

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 yetThe 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