Bioequivalence and Bioavailability Forum • Consumer risk

Consumer risk [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-03-08 13:13 (5581 d 06:39 ago) – Posting: # 6716
Views: 8,433

Hi Marcel,

❝ They have picked up on it and are calling us on it (one CMS only). We have used the standard 5% overall alpha. If I understand correctly, this is the consumer risk and it has remained the same, correct? The CMS is taking the position that aposteriori power is not sufficient. I'm trying to get my head around that. Seems to me they are confusing consumer risk with producer risk. Anything else you can add?

I can add that in such a situation I would keep cool.
If the CMS triggers a referral the CMS will probably be butchered by the other member states (assuming of course that no other issues exist and everything else is perfect). There is no other parameter than α which controls the consumer risk for a given formulation and comparison because the acceptance criterion is a 1 – 2×α CI for T/R.

You should of course point this out in a succinct manner in your response to the authorities.

—
Pass or fail!
ElMaestro

Complete thread:

Consumer risk Marcel 2011-03-08 10:56
- Consumer risk ElMaestro 2011-03-08 11:30
  - Consumer risk Marcel 2011-03-08 12:01
    - Consumer riskElMaestro 2011-03-08 12:13
    - A posteriori power - No.666 Helmut 2011-03-08 12:27
      - A posteriori power - No.666 Marcel 2011-03-08 12:50
        
        A posteriori power - No.666 ElMaestro 2011-03-08 13:06
        A posteriori power - No.666 Helmut 2011-03-08 13:41
        
        A posteriori power - No.666 Marcel 2011-03-08 14:13
        
        A posteriori power - No.666 Helmut 2011-03-08 14:27
        
        A posteriori power - No.666 Marcel 2011-03-08 14:49
        
        A posteriori power - No.666 Helmut 2011-03-08 15:03
        
        A posteriori power - No.666 Marcel 2011-03-08 15:28
        
        ... ElMaestro 2011-03-09 23:16