Bioequivalence and Bioavailability Forum • Sample Size estimation for Replicate Cross over studies FDA or EMA criteria

Sample Size estimation for Replicate Cross over studies FDA or EMA criteria [Power / Sample Size]

posted by Lara – Mexico, 2016-02-10 01:46 (2990 d 05:39 ago) – Posting: # 15966
Views: 24,697

Hi,

I have review the paper:

Someswara Roa. K et al. "Sample Size Estimation for Highly variable drugs using reference scaled average bioequivalence criteria". International Journal of Recent Scientific Research Vol. 6 Issue 7, pp.5040-5045, July, 2015.

They are determined the optimal sample size for reference scaled average bioequivalence under criteria of FDA and EMA. The paper has several tables with the sample size according with FDA and EMA criteria for the designs partial replicate 2x2x3 and full replicate 2x2x4 and use the BE limit. However, they are using the estimation of the sample size for a simple crossover. I am not sure that this is correct starting with df=2*n-2 and I do not know when they are using the characteristics of the designs. Can somebody help me with that?

Thanks

Lara

Edit: Category changed. [Helmut]

Complete thread:

Sample Size estimation for Replicate Cross over studies FDA or EMA criteriaLara 2016-02-10 00:46 [Power / Sample Size]
- Garbage d_labes 2016-02-10 08:34
  - Garbage nobody 2016-02-10 11:17
    - Garbage d_labes 2016-02-10 13:28
- Ponzi scheme Helmut 2016-02-10 20:42
  - Ponzi scheme Lara 2016-02-11 20:35
  - Ponzi scheme jag009 2016-02-16 19:55
    - Ponzi scheme Helmut 2016-02-17 12:29
      - Ponzi scheme sanketh.gupta 2016-03-07 06:21
        
        Education necessary d_labes 2016-03-07 11:20
        Dangerous nonsense Helmut 2016-03-07 14:21
        
        Clarifications to the Dangerous nonsense somu_korla 2016-03-09 08:17
        
        Absurd absurdity d_labes 2016-03-09 09:46
        Outright bizarre Helmut 2016-03-09 16:02
        
        Clarifications to Outright bizarre somu_korla 2016-03-10 08:44
        
        Science vs. fairy tales Helmut 2016-03-10 18:58
        
        Clarifications for Science vs. fairy tales somu_korla 2016-03-11 10:00
        Forlorne hope d_labes 2016-03-11 16:30
        
        Forlorne hope lechia 2016-08-05 22:52
        
        Forlorne hope nobody 2016-08-08 15:49
        
        Forlorne hope d_labes 2016-08-09 08:50