Bioequivalence and Bioavailability Forum • A wild guess

A wild guess [Surveys]

posted by ElMaestro – Denmark, 2014-10-24 00:47 (4252 d 15:06 ago) – Posting: # 13784
Views: 14,189

Hi Hötzi,

A wild guess: I think you are fiddling around with WHO Technical Report Series, No. 937, annex 7 (Multisource BlahDeeBlah),
specifically you might be looking at section 6.3.2: "If the bioequivalence study was performed with the appropriate number of subjects but bioequivalence cannot be demonstrated because of a larger than expected random variation or a relative difference, an add-on subject study can be performed using not less than half the number of subjects in the initial study, provided this eventuality was anticipated and provided for in the study protocol."
as well as 6.11.3: "the total sample size of the initial bioequivalence study is not less than 20 (n = 10/group) or pooled sample size of the initial and add-on subject studies is not less than 30;"

-which lend from the PMDA guidelines section 2.5.
In a nutshell you are trying to figure out how the overall alpha behaves for various scenarios, incl. adjusted alphas, anticipated to comply with the Japanese add-on recommendations.

—
Pass or fail!
ElMaestro

Complete thread:

Riddle Helmut 2014-10-23 20:11 [Surveys]
- Riddle nobody 2014-10-23 20:37
  - Riddle Helmut 2014-10-23 20:58
- A wild guessElMaestro 2014-10-23 22:47
  - Partly solved Helmut 2014-10-23 23:08
    - Partly solved ElMaestro 2014-10-23 23:19
      - Partly solved Helmut 2014-10-23 23:27
        
        Partly solved ElMaestro 2014-10-23 23:37
        
        Partly solved Helmut 2014-10-24 00:20
        
        Solved? d_labes 2014-10-24 13:13
        
        99 points! Helmut 2014-10-24 13:19
        
        For the tough ElMaestro 2014-10-24 14:19
        
        For the tough ones Helmut 2014-10-24 14:54
        
        99 points! nobody 2014-10-24 14:25
        
        99 points! Helmut 2014-10-24 15:01