Bioequivalence and Bioavailability Forum • Consumer risk

Consumer risk [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-03-08 12:30 (5590 d 02:21 ago) – Posting: # 6714
Views: 8,289

Hi Marcel,

❝ What is the consumer risk in having conducted a study with too few subjects (a posteriori judgement)? Despite this apparent lack of power, the confidence intervals were within the accepted range (80-125). Do you need more information than this to formulate a response?

The consumer risk is irrelevant at this stage. If you have proven BE with the standard 5% overall alpha then the product is BE.

The fact that you may have initiated the trial with a low number of subjects is of potential ethical concern, but that does not affect the product. If at all interested, they should pick up on this at the trial application stage.

It isn't against the law to have a bit of luck.

—
Pass or fail!
ElMaestro

Complete thread:

Consumer risk Marcel 2011-03-08 10:56
- Consumer riskElMaestro 2011-03-08 11:30
  - Consumer risk Marcel 2011-03-08 12:01
    - Consumer risk ElMaestro 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