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Testing equivalence between two laboratories or two methods using paired-sample analysis and interval hypothesis testing
Authors:Shixia Feng  Qiwei Liang  Robin D Kinser  Kirk Newland  Rudolf Guilbaud
Institution:(1) Philip Morris USA, Research Center, 4201 Commerce Road, Richmond, VA 23234, USA;(2) MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA;(3) MDS Pharma Services, 2350 Cohen Street, St. Laurent (Montreal), Quebec, H4R 2N6, Canada
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
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