Bioequivalence and Bioavailability Forum • Rivastigmine 6 mg: patients?

Rivastigmine 6 mg: patients? [Design Issues]

posted by ElMaestro – Denmark, 2009-08-22 19:47 (6149 d 17:20 ago) – Posting: # 4095
Views: 7,788

Dear Muneesh & all,

interesting reading in those references.
I noticed the following on page 13 in the first Epar:

"Hence, it is possible that the observed effect is due solely to chance. The least-squares means of the treatment effect were adjusted for the period effect."

In my opinion, the first sentence is an interesting way of saying absolutely nothing. The second sentence is meaningless given the way LSMeans are actually calculated. Makes you wonder, did I skip one of the lectures in statistics?!

Best regards
EM.

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 best Helmut 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