Bioequivalence and Bioavailability Forum

[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2018-03-28 21:07 (2013 d 23:05 ago) – Posting: # 18602
Views: 9,577

Hi bfan,

❝ I am a new poster, long time lurker. I am a clinical pharmacologist who is crazy (but not formally trained) about statistics.

I like that

The width of the confidence interval is generally sample size dependent. Whether or not 100% is included in your CI may have absolutely nothing to do with the performance of the two products, or the existence of a clinically relevant difference, but which may have everything to do with your chosen sample size.
If we implement the rule like you propose we will therefor be punishing those sponsors who have high sample sizes. Think about it - this isn't what anyone wants to do.

At the end of the day you know the two products are different (although they might not be different by any clinically meaningful margin). The fact that any two products are different is one you can generally prove by increasing the sample size until the CI no longer includes 100%.

Complete thread:

• [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 [RSABE / ABEL] 
  • [Opinion] Should the 90% CI for GMR be required to encompass 1ElMaestro 2018-03-28 19:07
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 19:23
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:44
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 20:05
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-28 21:25
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 21:59
              • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
                • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
                  • Black Swan again mittyri 2018-04-05 17:57
  • [Opinion] Should the 90% CI for GMR be required to encompass 1 Helmut 2018-03-28 23:57
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 13:46
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 16:52
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 16:57
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
              • Paper & Presentations Helmut 2018-03-30 01:33
            • Donald Schuirmann’s opinion Helmut 2018-04-10 14:41