Bioequivalence and Bioavailability Forum • PE outside the acceptance range

PE outside the acceptance range [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2016-01-11 15:02 (3018 d 08:14 ago) – Posting: # 15812
Views: 11,599

Hi Jay,

❝ It is pilot study with sample size of 18, with N=18, the GMR and IS %CV values for C_max, AUC_t and AUC_inf are 127.8 & 21.01, 105.1 & 16.71 and 105.49 & 16.73. The post hoc power observed is 2.4, 92.15 and 91.21 respectively.

I guess this was a 3×3 Latin Square or a 6×3 Williams’ design? Otherwise I don’t come close to your numbers. Post hoc power of a pilot study is even more useless than the one of a pivotal study. However, with a PE of C_max outside of the acceptance range I would strongly suggest to reformulate.

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Complete thread:

Post hoc Power Jay 2016-01-08 06:49 [Power / Sample Size]
- Post hoc Power ElMaestro 2016-01-08 15:07
- Post hoc Power Helmut 2016-01-09 14:21
  - Post hoc Power Jay 2016-01-11 10:59
    - PE outside the acceptance rangeHelmut 2016-01-11 14:02
      - PE outside the acceptance range Jay 2016-01-13 08:24
        
        Power for PE outside the acceptance range d_labes 2016-01-13 11:59
        PE at border of the AR: power ≡ 0.05 Helmut 2016-01-13 12:38
        
        PE at border of the AR: power ≡ 0.05 ? d_labes 2016-01-13 13:21
        
        PE at border of the AR: power ≤0.05! Helmut 2016-01-14 01:29
        
        UMP - uniformly more powerful test d_labes 2016-01-15 20:08
        PE at border of the AR: power ≤0.05! zizou 2016-01-24 22:12
        
        Smoothing artifact Helmut 2016-01-25 14:15