Bioequivalence and Bioavailability Forum

New paper (method D for PE 0.90) [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2011-04-19 10:58 (5542 d 12:12 ago) – Posting: # 6918
Views: 31,020

Dear Helmut, dear all,

❝ ... It might be possible to adjust the α level for methods B/C as well, but this has not been evaluated yet.

This sentence of the paper is confusing me somewhat .
As far as I had understood the method D is a variant of method C with adjusted alpha level.

Moreover I don't share the authors view of "excessive inflation of Type I error rate".
In view of other Type I inflation allowed by the FDA, f.i. the inflation around CV=30% for the scaled ABE up to 6.5%-7% due to the regulatory s_w0=0.25 (see this presentation, page 23) I would consider the inflations observed in the paper (max. 0.0547) marginal.

What makes me also wondering is that the alpha "inflation" is shifted to higher stage 1 number of subjects if the variability increases. This is somehow counter-intuitive to me. Small is beautiful?

Complete thread:

• Potvin method B subtleties d_labes 2011-01-31 14:24 
  • Potvin method B subtleties jdetlor 2011-02-01 17:17
    • Potvin method B subtleties d_labes 2011-02-02 09:15
      • Potvin method B subtleties jdetlor 2011-02-02 16:08
        • Gould d_labes 2011-02-02 16:25
          • Gould jdetlor 2011-02-02 17:02
  • Another one ... d_labes 2011-02-07 14:32
    • Oops! Helmut 2011-02-07 15:24
      • Oops! d_labes 2011-02-07 16:29
        • Oops! Helmut 2011-02-07 16:47
          • Oops! ElMaestro 2011-02-07 17:06
            • Oops! Helmut 2011-02-07 17:17
              • Oops! ElMaestro 2011-02-07 18:35
          • Simul'ants in my pants d_labes 2011-02-08 09:07
            • Need for speed... ElMaestro 2011-02-13 10:57
              • Need for speed... d_labes 2011-02-15 14:06
                • Need for speed... ElMaestro 2011-02-15 17:39
                  • Pocock alpha's d_labes 2011-02-16 09:18
                    • ElMaestro's brain ElMaestro 2011-02-16 09:32
                      • ElMaestro's brain d_labes 2011-02-16 10:05
                        • ElMaestro's brain ElMaestro 2011-02-16 12:07
                          • Numbers d_labes 2011-02-16 13:45
  • Bonus counter-question ElMaestro 2011-02-07 23:44
    • Speed is the question d_labes 2011-02-08 08:36
  • New paper (method D for PE 0.90) Helmut 2011-04-18 12:58
    • New paper (method D for PE 0.90)d_labes 2011-04-19 08:58
      • New paper (method D for PE 0.90) Helmut 2011-04-19 14:30
      • New paper (method D for PE 0.90) ElMaestro 2011-04-19 14:49
        • Stopping criterion # futility rule Helmut 2011-04-19 15:28