Bioequivalence and Bioavailability Forum • General BE topics

General BE topics [Design Issues]

posted by VSL – India, 2017-06-06 21:34 (2948 d 12:19 ago) – Posting: # 17455
Views: 17,647

Dear ElMaestro and Helmut,

Thank you very much for the explanation.

One more question, why regulatory agencies are allowing studies with deliberate high power? I mean, it is forced BE, unethical and violation of Declaration of Helsinki (Human exposure without scientific rationale). There has to be the scientific tradeoff in setting alfa and beta values while calculating sample size rather mere assumption. I have seen post analysis power more than 90% in many studies. If you ask biostatisticians, they say, we don't know, it comes, no justification is required as the study has passed.

Thank you again.

Complete thread:

General BE topics VSL 2017-06-05 20:34 [Design Issues]
- General BE topics ElMaestro 2017-06-06 00:20
- General BE topics Helmut 2017-06-06 14:24
  - General BE topicsVSL 2017-06-06 19:34
    - General BE topics DavidManteigas 2017-06-12 12:35
      - forced BE? Helmut 2017-08-04 15:51
        
        forced BE? DavidManteigas 2017-08-07 12:42
        
        forced BE? Helmut 2017-08-07 13:31
        
        forced BE? ElMaestro 2017-08-07 13:44
        
        forced BE? Helmut 2017-08-07 14:00
        
        forced BE? ElMaestro 2017-08-07 15:58
        
        forced BE? DavidManteigas 2017-08-07 14:02
        
        forced BE? Helmut 2017-08-07 14:26