Bioequivalence and Bioavailability Forum • Garbage

Garbage [Power / Sample Size]

posted by d_labes – Berlin, Germany, 2016-02-10 09:34 (3782 d 06:45 ago) – Posting: # 15967
Views: 26,583

Dear Lara,

❝ 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.

forget this "gem" of science literature. It's simply crap. Don't believe even in comma of this paper. Throw it in a high arc into your waste bin.

Use instead:
Laszlo Tothfalusi and Laszlo Endrenyi
"Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"
J Pharm Pharmaceut Sci (www.cspsCanada.org) 15(1) 73 - 84, 2011
Online here.

The described simulation approach to get power/sample size is implemented in the R-package PowerTOST.

—
Regards,

Detlew

Complete thread:

Sample Size estimation for Replicate Cross over studies FDA or EMA criteria Lara 2016-02-10 00:46
- Garbaged_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