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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Author(s):
Separovic, Luciana [1] ; Simabukuro, Renan S. [1] ; Couto, Aldo R. [1] ; Bertanha, Maria Luiza G. [1] ; Dias, Francielle R. S. [1] ; Sano, Adriano Y. [1] ; Caffaro, Arthur M. [1] ; Lourenco, Felipe R. [1]
Total Authors: 8
Affiliation:
[1] Univ Sao Paulo, Dept Farm, Fac Ciencias Farmaceut, Sao Paulo - Brazil
Total Affiliations: 1
Document type: Review article
Source: CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY; JUN 2021.
Web of Science Citations: 0
Abstract

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)

FAPESP's process: 18/25734-0 - Measurement uncertainty in performance evaluation of analytical methods and improvement strategies using analytical quality by design
Grantee:Luciana Separovic
Support type: Scholarships in Brazil - Doctorate (Direct)
FAPESP's process: 19/15549-4 - Measurement uncertainty associated with the microbial counts of pharmaceutical products
Grantee:Francielle Regina Silva Dias
Support type: Scholarships in Brazil - Master
FAPESP's process: 19/16206-3 - Risks of false decisions due to the measurement uncertainties in the evaluation of pharmaceutical equivalence
Grantee:Felipe Rebello Lourenço
Support type: Regular Research Grants