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, 2018-03-29 01:57 (2602 d 22:55 ago) – Posting: # 18611
Views: 11,892

Hi ElMaestro,

❝ 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.

This is what I was looking for. Thank you for lending your knowledge!

The problem I describe may already exist for e.g. levothyroxine, with a Swr around 0.2, and many narrowly separated strengths (e.g. 100, 112, 125 mcg).

Using FDA NTID guidelines, I think it would be plausible to pass a formulation with GMR of 1.03-1.09 and another with a GMR of 0.93 - 0.99. In that case, a 100mcg tablet w/ GMR of 1.03-1.09 and 112mcg tablet w/ GMR of 0.93-0.99 would be biologically indistinguishable, which is concerning.

So we figured out that my proposed solution is not a good idea. How would you go about solving it?

Cheers,
BF

Complete thread:

[Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43
- [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 1 ElMaestro 2018-03-28 23:03
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1bebac_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