抄録
Even if repeated measurements are performed under the same assumptions, the results will vary. This variation is called measurement precision. The dose-response relationship refers to the relationship between the dose of a substance, such as a drug, and the response of an organism. It is useful for pharmaceuticals and safety evaluations. However, while a methodology, ISO 5725, exists for quantifying measurement precision, it only applies to quantitative data, such as length and weight, and not to qualitative data, such as the presence or absence of a response, which is the subject of this study. Therefore, the authors propose an accuracy evaluation model based on logistic regression that considers the dose-response relationship. In the model, the between-laboratory variance can be quantified by two indices, the position and slope of the dose-response curve, to determine which variance is relatively larger. The consistency between true values and estimated values was confirmed by simulation. and the within-laboratory variance can be estimated to obtain the variance of residuals in single regression analysis. By applying the proposed model to actual data, the measurement precision could be quantified and demonstrated. This model can improve the reliability of measurement precision evaluations in qualitative data considering the dose-response relationship.