Determination of Intrinsic and Metrological Correlations of Components of Product Impact on Risks of False Decisions in Conformity Assessment

摘要

The correlation between the measured values of product components can influence the total risk of false decisions in conformity assessment. This correlation can originate from the characteristics of the product (intrinsic) or from how the components are measured (metrological). This work aimed to determine both correlations by testing a medicine with two compounds separately and together (correlated). The same intrinsic correlation was estimated regardless of whether the measurements were independent or correlated. Furthermore, the intrinsic covariance contributed significantly to the total covariance between the components evaluated. Both metrological and intrinsic correlations should be considered, as they can affect the risks of false decisions in conformity assessment when there are two or more compounds associated in the product.