Bioequivalence and Bioavailability Forum • sample size for BA/BE studies

sample size for BA/BE studies [Regulatives / Guidelines]

posted by drmuneesh – 2008-10-18 11:17 (6448 d 14:23 ago) – Posting: # 2553
Views: 10,576

Dear all
I would like to know the globally accepted formula used sample size calculation for Bioequivalence studies. Which are the parameters should be available for the calculation of the sample size? Are there any valid software available to do so? In case we have only the data like Mean +/- S.D. then how to calculate N? What will be the minimum N to be considered for pivotal studies? Kindly provide me detailed answer for my clarification on sample size calculation. Thanks to everybody in advance...

With kind regards

Muneesh

Complete thread:

sample size for BA/BE studiesdrmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
- sample size for BA/BE studies shankar 2008-10-18 11:47
  - sample size for BA/BE studies drmuneesh 2008-10-18 12:18
    - sample size for BA/BE studies Ohlbe 2008-10-18 13:32
      - sample size for BA/BE studies drmuneesh 2008-10-19 10:42
      - sample size for BA/BE studies drmuneesh 2008-11-17 14:10
        
        sample size for BA/BE studies ElMaestro 2008-11-17 14:32
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:34
        sample size for BA/BE studies drmuneesh 2008-11-28 07:50
        
        sample size for BA/BE studies Helmut 2008-11-17 15:47
        
        sample size for BA/BE studies drmuneesh 2008-11-18 07:44
        
        sample size for BA/BE studies ElMaestro 2008-11-18 08:49
        
        sample size for BA/BE studies drmuneesh 2008-11-18 09:31
        
        sample size for BA/BE studies ElMaestro 2008-11-18 09:59
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:27
        
        sample size for BA/BE studies drmuneesh 2008-11-19 10:14
        
        sample size for BA/BE studies ElMaestro 2008-11-19 10:48
        
        sample size for BA/BE studies drmuneesh 2008-11-20 08:30
        
        CVintra # CVinter # CVtotal Helmut 2008-11-20 11:18
        
        Circulus vitiosus d_labes 2008-11-20 13:57
        
        Sterne! Helmut 2008-11-20 18:11
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-28 10:37
        
        CVintra # CVinter # CVtotal Helmut 2008-11-29 10:14
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-30 07:18
        
        is something fishy in case 2? ElMaestro 2008-11-29 15:42
        
        is something fishy in case 2? drmuneesh 2008-11-30 07:17
        
        SAS and sample size d_labes 2008-11-19 11:33
        
        SAS and sample size drmuneesh 2008-11-20 08:31