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RegisterEMEA at its best [Design Issues]
posted by Helmut 
– Vienna, Austria, 2009-08-22 20:37 (6153 d 13:19 ago) – Posting: # 4096
Views: 7,765
¡ Hola ElMaestro !
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:
Again (maybe we have readers in London, UK):
❝ [...] 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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE study of Rivastigmine 6 mg in healthy volunteers drmuneesh 2009-08-21 10:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Rivastigmine BE Dr Lalit 2009-08-25 14:41
- EMEA at its best drmuneesh 2009-08-25 06:12
- EMEA at its best drcampos 2009-08-24 19:26
- EMEA at its best drmuneesh 2009-08-24 13:59
- EMEA at its best ElMaestro 2009-08-22 19:17
- EMEA at its bestHelmut 2009-08-22 18:37
- Rivastigmine 6 mg: patients? drmuneesh 2009-08-22 06:51
- Rivastigmine 6 mg: patients? Helmut 2009-08-21 23:17
Ing. Helmut Schütz