Bioequivalence and Bioavailability Forum

Power testing [Power / Sample Size]

posted by d_labes  – Berlin, Germany, 2013-02-11 13:03 (4460 d 00:02 ago) – Posting: # 10001
Views: 10,535

Dear Helmut!

Thank you so much for this comprehensive testing !
Saves me a lot of work.

Can you give me a statement on the validity of power.scABEL() and sampleN.scABEL()?

❝ I will ask them whether they have used 0.89 like in their paper from 2009 instead of log(1.25)/0.25 ≈ 0.8925742…

Maybe some of the differences in case of regulator="FDA" are due to the widened ABEL approach instead of the approach via the linearized SABE criterion and its 95% upper confidence limit <0.
Again: Coming soon ... or later ...

But if you ask them: Ask in this respect if they have used "The unknown x" used in the SAS code of the progesterone guidance in their implementation of the linearized SABE criterion. I haven't found any hint in their papers on HVD/HVDP regarding such a 'correction' for the upper CI part of the point estimator.

Complete thread:

• Sample size for RSABE Anu 2013-02-01 07:01 
  • Sample size for RSABE d_labes 2013-02-01 09:46
    • Sample size for RSABE Anu 2013-02-07 06:58
      • No analytic solution! Helmut 2013-02-07 12:32
        • Coming soon ... d_labes 2013-02-08 11:57
          • Wow! Helmut 2013-02-08 12:19
            • Wow! Anu 2013-02-09 09:20
              • read… Helmut 2013-02-09 09:35
            • Bigamist d_labes 2013-02-09 18:11
              • Some testing (Part I) Helmut 2013-02-10 18:35
              • Some testing (Part II) Helmut 2013-02-11 01:00
                • Power testingd_labes 2013-02-11 12:03
                  • the unknown x Helmut 2013-02-11 14:40
                • Unequal CVs d_labes 2013-02-15 08:47
                  • Typo Helmut 2013-02-15 13:01