Bioequivalence and Bioavailability Forum • Table A3

Table A3 [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2013-10-18 15:51 (4634 d 20:59 ago) – Posting: # 11696
Views: 17,474

Hi Niraj,

24 is correct. But, if you assume a CV_WR of 30% the probability of not being allowed to scale is 50%. So it might well be possible that you will be trapped in the situation described in my previous post – therefore, forget the partial replicate! Don’t assume a GMR of 0.95 for HVDs/HVDPs. If you run the study in 24 subjects and the GMR is 0.9, power will be only 59%.

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Helmut Schütz

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Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
- sample size for partial replicate - USFDA jag009 2013-10-17 15:09
  - sample size for partial replicate - USFDA niraj.bhatt 2013-10-18 08:18
    - Table A3Helmut 2013-10-18 13:51
      - N=24 or N=27 d_labes 2013-10-18 14:34
        
        in praise of 100,000 sim’s Helmut 2013-10-18 15:02
        N=24 or N=27 niraj.bhatt 2013-10-19 06:19
      - Table A3 niraj.bhatt 2013-10-19 06:18
- forget the partial replicate Helmut 2013-10-18 00:14
  - forget the partial replicate niraj.bhatt 2013-10-18 07:57
    - PowerTOST and RSABE d_labes 2013-10-18 11:16
  - Replicate Pilot study kumarnaidu 2014-04-11 07:37
    - Replicate Pilot study ElMaestro 2014-04-11 10:27
      - Replicate Pilot study kumarnaidu 2014-04-11 12:45
        
        Replicate Pilot study ElMaestro 2014-04-11 13:23
        
        Replicate Pilot study kumarnaidu 2014-04-14 06:22