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

Abstract

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.

Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design

“…Neste trabalho focamos nos riscos particulares globais estimados pela abordagem Bayesiana 119 e riscos particulares específicos estimados pela abordagem frequentista 141 . Estes riscos são chamados particulares por levar em consideração somente um parâmetro de qualidade do produto (o teor do princípio ativo, no caso deste trabalho), diferente do risco total que leva em consideração dois ou mais parâmetros de qualidade, assim como foi abordado em estudos prévios 136,142,143 .…”