Bioequivalence and Bioavailability Forum • Maybe

Maybe – but why? [RSABE / ABEL]

posted by Ben – 2012-10-23 18:03 (4630 d 20:17 ago) – Posting: # 9448
Views: 8,971

Dear Helmut,

Thank you for the quick response. Regarding the model, well, I would use the one the FDA/EMA wants to see (as you wrote) ;-)

. But that's not the point.

❝ Counter-question: Why would you attempt that?

I want to present the two approaches to non-statisticians: Statement when SABE is achieved and how the scaled acceptance region looks like. Therefore I would like to use the 90% CI (to which they are used to) and the well known acceptance region 0.8 - 1.25 and the scaled version of it, respectively. I believe the 95% upper limit approach could cause confusion...

Thanks,
Ben

Complete thread:

Replicate Design: Scaling FDA Ben 2012-10-23 11:32 [RSABE / ABEL]
- Maybe – but why? Helmut 2012-10-23 15:35
  - Maybe – but why?Ben 2012-10-23 16:03
    - Got it. Helmut 2012-10-23 16:23
  - FDA Mixed up d_labes 2012-10-23 16:23
    - FDA Mixed up Helmut 2012-10-23 16:34
  - Maybe – but why? Ben 2012-10-27 17:04
    - Maybe – but why? Helmut 2012-10-27 17:57
      - Maybe – but why? Ben 2012-10-28 13:57
        
        Potvin (and beyond?) Helmut 2012-10-28 15:59
        
        Potvin (and beyond?) Ben 2012-11-01 10:17