Bioequivalence and Bioavailability Forum

throw away our sample size tables? [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2013-03-26 17:02 (2970 d 00:44 ago) – Posting: # 10289
Views: 18,197

Hi Martin!

» iteratively adjusted alpha – super idea!

If the inflation of the consumer’s risk is real (based on our assumption to estimate pBE with a GMR at the borders of the scaled acceptance range) regulators should revise their methods. Would increase the sample size and IMHO requires a multi-step procedure.

1. Estimate the sample size for unadjusted α
   
2. Estimate adjusted α for this n
   
3. Estimate the sample size for adjusted α
   
4. Repeat steps 2–3 until you are in limbo

» […] two weirdos published a paper […]

Not their only crime.

—
Dif-tor heh smusma 🖖
Helmut Schütz


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Science Quotes

Complete thread:

• ‘alpha’ of scaled ABE? d_labes 2013-03-15 15:56 [RSABE / ABEL] 
  • ‘alpha’ of scaled ABE? Helmut 2013-03-15 17:27
    • ’alpha’ of scaled ABE: design d_labes 2013-03-16 20:10
      • N=24, 48 d_labes 2013-03-18 08:11
        • adaptive design without adjustment martin 2013-03-25 20:47
          • α adjustment? Helmut 2013-03-26 15:21
            • iteratively adjusted alpha martin 2013-03-26 16:19
              • throw away our sample size tables?Helmut 2013-03-26 18:02
                • if real martin 2013-03-26 19:44
                  • regulators don’t care? Helmut 2013-03-26 21:18
                • adjusting α Helmut 2013-08-11 16:19
              • target α in sim’s? Helmut 2013-03-27 15:38
                • target α in sim’s? martin 2013-03-27 16:36
                  • If it is real: results Helmut 2013-03-28 23:20
                • having alpha martin 2013-03-28 15:08
                  • fixed swr Helmut 2013-03-28 23:34
                    • fixed swr martin 2013-03-29 15:07
                      • Yes but no but yes but no but… Helmut 2013-03-29 16:10