Bioequivalence and Bioavailability Forum • When is a BE study futile?

When is a BE study futile? [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-10-31 10:17 (5348 d 19:00 ago) – Posting: # 7563
Views: 10,594

Hi all,

what is your perceived absolute minimum limit for prospective power in order for a trial to be ethical and non-futile?

My own opinion would be 80%, but I do acknowledge that (fortunately!) the rest of the world rarely agrees with me and the limit in practice differs from IEC/IRB to IEC/IRB etc.

Best regards,
EM

Complete thread:

When is a BE study futile?ElMaestro 2011-10-31 09:17
- When is a BE study futile? Dr_Dan 2011-10-31 09:46
  - When is a BE study futile? ElMaestro 2011-11-01 09:59
    - Power in the 2-stage design d_labes 2011-11-01 10:28
- When is a BE study futile? Dr_Dan 2011-10-31 12:55
- When is a BE study futile? Helmut 2011-10-31 14:41
  - When is a BE study futile? vinayshed 2011-11-01 05:59
- Minimum target power? d_labes 2011-11-01 10:04
  - ethics and power ElMaestro 2011-11-01 10:46
    - ethics and power d_labes 2011-11-01 11:28
      - ethics and power Ohlbe 2011-11-01 22:57
        
        ethics and power ElMaestro 2011-11-02 09:27
        
        ethics and power Ohlbe 2011-11-02 11:00
    - ethics and power Dr_Dan 2011-11-01 13:10
      - ethics and power ElMaestro 2011-11-01 13:53
        
        When does power become unethical? Dr_Dan 2011-11-02 10:55
        
        When does power become unethical? ElMaestro 2011-11-02 12:01