Bioequivalence and Bioavailability Forum

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

posted by ElMaestro  – Denmark, 2018-03-29 01:03 (2013 d 18:42 ago) – Posting: # 18610
Views: 9,573

Hi bf,

❝ I was using the 100/112/125 example...

there are two things in this:

1. In some cases the usual 80.00%-125.00% criterion may not be optimal and in those cases alternatives must be sought.
   
2. I am not aware of any problem of any kind, which has practical relevance and which can be solved by imposing a mandatory span for the CI across the 100% mark.

The example you mention appears very hypothetical, doesn't it?
If it existed that way then you could definbitely do a Finney bioassay to derive relative potency and a CI of the same. Now that's a horse of another color.

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 1 ElMaestro 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 1ElMaestro 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