Bioequivalence and Bioavailability Forum

Null = bioINequivalence [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2010-10-25 21:16 (5373 d 06:19 ago) – Posting: # 6078
Views: 16,378

Dear Jack!

❝ this is quite a complex question…

True.

❝ … to which I will add some more questions.

Well, I think the applicability of commonly used methods is questionable, because of the different way the Null is formulated in BE studies.

Just a quote from Potvin et al.,* after referring different approaches:

Regardless, none of the methods are validated for crossover studies and two one-sided t-tests, so there is a need to start from the beginning in considering these approaches.

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• Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008;7(4):245–62. doi:10.1002/pst.294.

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


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Complete thread:

• 2-stage design with interim sample size estimation d_labes 2010-10-05 15:09 [Two-Stage / GS Designs] 
  • 2-stage design with interim sample size estimation Jack 2010-10-25 18:20
    • Null = bioINequivalenceHelmut 2010-10-25 19:16
    • 2-stage design with interim sample size estimation d_labes 2010-10-26 13:28
      • 2-stage design with interim sample size estimation Jack 2010-10-26 18:26
        • Blind or not, Indecisions or Decisions d_labes 2010-10-27 16:01
          • Blind or not, Indecisions or Decisions Jack 2010-10-27 18:14
            • Blind ? Ohlbe 2010-10-27 23:37
              • Blind ? Jack 2010-10-28 10:24
                • Blind 2Stage Astea 2019-05-30 10:37
                  • Blind 2Stage Helmut 2019-05-30 12:56
                    • Blind 2Stage and an elephant Astea 2019-05-31 14:36
                      • Which elephant? Helmut 2019-06-02 20:14
                        • Blind interim in parallel design? Astea 2019-06-03 01:47
                          • Blind men d_labes 2019-06-05 12:23
                            • The Blind Leading the Blind Astea 2019-06-06 00:55