Analytical and Bioanalytical Chemistry

, Volume 385, Issue 5, pp 975–981 | Cite as

Testing equivalence between two laboratories or two methods using paired-sample analysis and interval hypothesis testing

  • Shixia Feng
  • Qiwei Liang
  • Robin D. Kinser
  • Kirk Newland
  • Rudolf Guilbaud
Technical Note

Abstract

A modified interval hypothesis testing procedure based on paired-sample analysis is described, as well as its application in testing equivalence between two bioanalytical laboratories or two methods. This testing procedure has the advantage of reducing the risk of wrongly concluding equivalence when in fact two laboratories or two methods are not equivalent. The advantage of using paired-sample analysis is that the test is less confounded by the intersample variability than unpaired-sample analysis when incurred biological samples with a wide range of concentrations are included in the experiments. Practical aspects including experimental design, sample size calculation and power estimation are also discussed through examples.

Keywords

Equivalence Interval hypothesis testing Paired-sample analysis Bioanalysis Comparability 

Notes

Acknowledgement

The authors would like to thank Drs. Hans Roethig and Mohamadi Sarkar for helpful discussion and suggestions.

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Shixia Feng
    • 1
  • Qiwei Liang
    • 1
  • Robin D. Kinser
    • 1
  • Kirk Newland
    • 2
  • Rudolf Guilbaud
    • 3
  1. 1.Philip Morris USAResearch CenterRichmondUSA
  2. 2.MDS Pharma ServicesLincolnUSA
  3. 3.MDS Pharma ServicesSt. Laurent (Montreal)Canada

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