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Abstract:
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A fundamental assumption of bioanalytical method (assay) is that the test sample behaves as a dilution or concentration of the standard sample. Thus, assessing similarity is a crucial part in a bioanalytical study. The common approach for assessing similarity is standard ANOVA analysis, which punishes the precise assay rather than poor assay. To overcome this problem, we propose a technique based on the idea of equivalence test but comparing the shape of curve directly. The new method measures the difference of response between the standard sample and test sample over concentration (dilution) levels and then justifies whether the difference is consistent by comparing them to the equivalence limit. The sensitivity and specificity of our method were investigated by the simulation study which shows that the new method does not suffer from the drawbacks of the conventional approaches.
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