Bioequivalence and Bioavailability Forum • Sequential trial with B method of Potvin

Sequential trial with B method of Potvin [Two-Stage / GS Designs]

posted by john john – Spain, 2015-10-01 19:44 (3562 d 11:31 ago) – Posting: # 15513
Views: 13,944

In a sequential clinical trial conducted like a B method of Potvin, we have Cmax and AUC both not bioequivalent. Cmax has a power <80% (71.5%), and AUC>80% (84.6%).
AUC 0-30min calculated by protocol is bioequivalent.
In the protocol it was not specified how to proceed in this situation.

Can we calculate a new n and pass to the second phase? Or we must stop the trial?

Thanks

Edit: Category changed. [Helmut]

Complete thread:

Sequential trial with B method of Potvinjohn john 2015-10-01 17:44 [Two-Stage / GS Designs]
- Sequential trial with B method of Potvin ElMaestro 2015-10-01 17:58
- Sequential trial with B method of Potvin Helmut 2015-10-01 18:13
  - Sequential trial with B method of Potvin john john 2015-10-07 11:26
    - Power to the people d_labes 2015-10-07 13:49
      - Power to the people john john 2015-10-07 14:54
        
        Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
        
        Subtraction of a df ElMaestro 2015-10-07 21:22
        
        df = df-1 d_labes 2015-10-08 08:10
    - Potvin B: α 0.0294 in both stages Helmut 2015-10-08 15:27
      - Potvin B: α 0.0294 in both stages john john 2015-10-23 12:04