Bioequivalence and Bioavailability Forum • Sample size for replicate design partial AUC

Sample size for replicate design partial AUC [Power / Sample Size]

posted by AngusMcLean – USA, 2014-06-25 04:11 (3960 d 19:17 ago) – Posting: # 13137
Views: 19,092

We have early partial AUC data from a completed study and the CV (%) for the early partial AUC intrasubject between formulation variance is 30.5%. The reason we have measured the partial AUC is that we are required by the FDA to submit BE data on the partial AUC metric when performing a pivotal BE study.

The question arises if we should use a replicate study design. I am thinking "yes" and thinking in terms of a full replicate design comparing test and reference formulations.

I am thinking in terms of estimating sample size and power. Are there Tables available for estimating the sample size and power of such study designs I have information here only for nonrepliciate BE study designs.

Comments are most welcome on this topic,

Angus

Complete thread:

Sample size for replicate design partial AUCAngusMcLean 2014-06-25 02:11
- sampleN.RSABE() Helmut 2014-06-25 02:53
  - sampleN.RSABE() AngusMcLean 2014-06-25 13:42
    - sampleN.RSABE() Helmut 2014-06-25 15:02
      - sampleN.RSABE() AngusMcLean 2014-06-25 20:05
        
        sampleN.RSABE() Helmut 2014-06-25 21:29
        
        sampleN.RSABE() AngusMcLean 2014-06-27 17:37
      - power2.TOST() d_labes 2014-06-30 09:47
        
        power2.TOST() Helmut 2014-06-30 12:02
        
        power2.TOST() ElMaestro 2014-06-30 12:31
        
        Elementary, my dear Watson! Helmut 2014-06-30 12:43
        
        Elementary, my dear Watson! ElMaestro 2014-06-30 13:07