Bioequivalence and Bioavailability Forum • But what is the real problem?

But what is the real problem? [Two-Stage / GS Designs]

posted by ElMaestro – Belgium?, 2018-06-07 13:53 (903 d 12:00 ago) – Posting: # 18863
Views: 3,156

Hi Yura,

you do your study as best you can, making some assumoptions -good or bad- about GMR and CV.
At the end of the day you may show BE or not, and if you do, then it may be with a large or small margin. I guess forced BE just means the margin was large whatever that means quantitatively.
There is no real issue here. The discussions I have seen about BE consider forced BE as a hindsight phenomenon, like post-hoc power.

If you start fiddling with "forced BE" being convincingly planned before a trial then I would of course oppose it.

Remember: In principle, either the product is BE or it isn't. There just happens to be some uncertainty on the degree by which we can demonstrate it.

—
I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Two-stage design and 'forced bioequivalence' Mikalai 2018-06-06 08:28 [Two-Stage / GS Designs]
- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53
  - Two-stage design and 'forced bioequivalence' Yura 2018-06-07 10:24
    - But what is the real problem?ElMaestro 2018-06-07 13:53
      - But what is the real problem? Yura 2018-06-07 14:59
        
        But what is the real problem? Mikalai 2018-06-07 15:47
        
        But what is the real problem? Helmut 2018-06-07 17:33
        
        But what is the real problem? Mikalai 2018-06-08 12:24
        
        U as a futility criterion Helmut 2018-06-08 14:00