Bioequivalence and Bioavailability Forum

Oops! [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2011-02-07 16:24 (5249 d 04:56 ago) – Posting: # 6568
Views: 26,946

Dear D. Labes,

good question, next question!

Let’s look at example 1 / method B/C: In stage 1 CI 104.27-134.17% (CV 14.56%) and PE 118.28%. Power for method B (α 0.0294) is reported with 75.6% (I get 76.3%) and for method C (α 0.05) is reported with 84.1% (I get 85.1%). Maybe the discrepancy comes from using Hauschke’s approximations?^*
Anyhow, the important point is that the calculation is based on T/R of 95% and not the actual 118.28%!
I missed that completely…

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• Hauschke D, Steinijans VW, Diletti E and M Burke
  Sample Size Determination for Bioequivalence Assessment Using a Multiplicative Model
  J Pharmacokin Biopharm 20/5, 557-561 (1992)

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Edit: My modification of Hauschke’s approximations (which gives the sample size, not power) comes up with 76.7% (α 0.0294) and 84.6% (α 0.05). No idea how Potvin et al. got their values.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

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