Bioequivalence and Bioavailability Forum • EMEA at its best

EMEA at its best [Design Issues]

posted by Helmut – Vienna, Austria, 2009-08-22 20:37 (6147 d 15:58 ago) – Posting: # 4096
Views: 7,735

¡ Hola ElMaestro !

❝ [...] Makes you wonder, did I skip one of the lectures in statistics?!

No, but these guys at EMEA did. When I read the assessment report this morning I couldn't believe it either. But in my experience part of the problem are sponsors's [cough...] 'not so good statisticians' (or CRO's). I have seen many reports were people found a significant treatment of even period [sic!] effect, and wrote lenghty essays in the discussion section that these effects are of no clinical relevance.
Maybe EMEA reacts like:

'Ah, very interesting, they have found something and dealt with it.
Thank you very much, well done, good guys, etc., bla bla.'

Again (maybe we have readers in London, UK):

Significant treatment effects are irrelevant in BE.
Any period effect in a cross-over study simply cancels out.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Complete thread:

BE study of Rivastigmine 6 mg in healthy volunteers drmuneesh 2009-08-21 10:59
- Rivastigmine 6 mg: patients? Helmut 2009-08-21 23:17
  - Rivastigmine 6 mg: patients? drmuneesh 2009-08-22 06:51
    - Rivastigmine 6 mg (EU centralised procedure) Helmut 2009-08-22 13:56
    - Rivastigmine 6 mg: patients? ElMaestro 2009-08-22 17:47
      - EMEA at its bestHelmut 2009-08-22 18:37
        
        EMEA at its best ElMaestro 2009-08-22 19:17
        
        EMEA at its best drmuneesh 2009-08-24 13:59
        
        EMEA at its best drcampos 2009-08-24 19:26
        
        EMEA at its best drmuneesh 2009-08-25 06:12
        
        Rivastigmine BE Dr Lalit 2009-08-25 14:41
        
        Rivastigmine BE drmuneesh 2009-08-26 06:29