Bioequivalence and Bioavailability Forum • pilot replicate design

pilot replicate design [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2014-11-19 16:18 (3828 d 20:26 ago) – Posting: # 13883
Views: 9,156

Hi Khaoula,

I agree with ElMaestro. The FDA requires 24 dosed subjects in replicate studies intended for RSABE, but only for the pivotal studies. The number of eligible subjects can be lower.

As usual the impact of the ratio on the estimated sample size of the pivotal study is higher than the one of the CV (which is taken care in RSABE anyway). Therefore, I would not design the pilot in a small number of subjects. For HVDs the GMR jumps around like crazy between studies. Don’t be tempted to assume a GMR too close to 1 even if you observed it in a pilot. That’s why the two Lászlós suggested a GMR of 0.9 in study planning.

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Helmut Schütz

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Complete thread:

pilot replicate design khaoula 2014-11-19 12:00
- pilot replicate design ElMaestro 2014-11-19 12:38
  - pilot replicate design khaoula 2014-11-19 14:11
    - N=24?? ElMaestro 2014-11-19 14:29
    - pilot replicate designHelmut 2014-11-19 15:18
      - pilot replicate design khaoula 2014-11-19 15:57
        
        Futile… Helmut 2014-11-20 14:39
        
        new information khaoula 2014-11-21 12:19
        kinetica khaoula 2014-11-22 10:38
        
        kinetica Helmut 2014-11-22 12:43