Bioequivalence and Bioavailability Forum • Maybe

Maybe – but why? [RSABE / ABEL]

posted by Ben – 2012-10-27 19:04 (4582 d 11:19 ago) – Posting: # 9470
Views: 8,619

Dear Helmut,

Thanks again for the fresh Mehl.
I have another question regarding your slides (Moscow). On slide 74 you write "Don’t jeopardize! Smaller sample sizes in the first stage than in a fixed design don’t pay off. Total sample sizes are ~10–20% higher."
What exactly do you mean by that? If the sample size from the first stage is chosen to be equal to the fixed design, then why performing a sequential design at all? Then the only chance of concluding BE (if not after stage 1) after all is to have a greater sample size than a fixed design; but this means that one always has a sample size greater or equal to fixed design - no possibility for having less any more...

Best,
Ben

Complete thread:

Replicate Design: Scaling FDA Ben 2012-10-23 11:32
- Maybe – but why? Helmut 2012-10-23 15:35
  - Maybe – but why? Ben 2012-10-23 16:03
    - Got it. Helmut 2012-10-23 16:23
  - FDA Mixed up d_labes 2012-10-23 16:23
    - FDA Mixed up Helmut 2012-10-23 16:34
  - Maybe – but why?Ben 2012-10-27 17:04
    - Maybe – but why? Helmut 2012-10-27 17:57
      - Maybe – but why? Ben 2012-10-28 13:57
        
        Potvin (and beyond?) Helmut 2012-10-28 15:59
        
        Potvin (and beyond?) Ben 2012-11-01 10:17