Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses - A Review

Autor(es)

Separovic, Luciana ; Simabukuro, Renan S. ; Couto, Aldo R. ; Bertanha, Maria Luiza G. ; Dias, Francielle R. S. ; Sano, Adriano Y. ; Caffaro, Arthur M. ; Lourenco, Felipe R.

• Tipo de documento: Artigo Científico
• Fonte: CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY; v. 53, n. 1, p. 16-pg., 2021-06-08.

Resumo

Analytical results are often used in scientific research, industrial and clinical applications to support decision making. Despite all efforts to ensure the reliability of analytical results (including method validation, internal quality control, use of certified reference materials, proficiency tests, and ISO 17025 accreditation), there will always be an uncertainty associated with the measured value. The measurement uncertainty expresses the quality of the analytical result and allows the comparability between analytical results or between the measured value and the specification limit(s). This work discusses the importance of measurement uncertainty, including the steps involved in the measurement uncertainty evaluation, the bottom-up and top-down approaches used in measurement uncertainty calculation, the measurement uncertainty evaluation in drug and medicine analyses, and the application of measurement uncertainty in conformity assessment for quality control, stability studies, and pharmaceutical equivalence. (AU)

• Processo FAPESP: 19/16206-3 - Riscos de decisões falsas quanto a avaliação de equivalência farmacêutica devido as incertezas de medições
• Beneficiário: Felipe Rebello Lourenço
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 18/25734-0 - Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do analytical quality by design
• Beneficiário: Luciana Separovic
• Modalidade de apoio: Bolsas no Brasil - Doutorado Direto
• Processo FAPESP: 19/15549-4 - Incerteza de medição associada à contagem microbiana de produtos farmacêuticos
• Beneficiário: Francielle Regina Silva Dias
• Modalidade de apoio: Bolsas no Brasil - Mestrado