Bioequivalence and Bioavailability Forum • [Opinion] Should the 90% CI for GMR be required to encompass 1

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

posted by bebac_fan – US, 2018-03-28 22:05 (2212 d 11:55 ago) – Posting: # 18605
Views: 10,006

Dear ElMaestro,

You said:

❝ If you have reason to think the product is BE, then you have reason to apply a sample size appropriate for demonstrating it.

I fully agree with this - which is why i brought up that example. In the previous post you mentioned that we don't want to punish folks with large sample sizes. My intent is prevent maliciously large sample sizes.

Perhaps one way to do so is impose a GMR of 1 within CI limit, and the other is to enforce appropriate sample size. The latter requires assumption of Swr and power, which could be potentially exaggerated.

❝ Can you re-word this? I cannot understand what you mean.

Sorry for my english. Assume there is a current drug approved at doses 100, 112, and 125mg. The difference in dosing is clinically important.

My motivation for the original question: it is conceivable that a one could find T(100mg) and R(112mg) BE with a large enough sample. It is also conceivable that one may find 125mg BE with 112mg. This would cause substantial risk of harm. I thought that perhaps imposing the CI through GMR of 1 limit may prevent this from happening.

Thanks,
BF

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 1bebac_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