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Measurement uncertainty in performance evaluation of analytical methods and improvement strategies using analytical quality by design

Grant number: 18/25734-0
Support type:Scholarships in Brazil - Doctorate (Direct)
Effective date (Start): August 01, 2019
Effective date (End): September 30, 2021
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal researcher:Felipe Rebello Lourenço
Grantee:Luciana Separovic
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil


The analytical methods used in quality control of medicines should be validated according to the criteria of national and international guides. However, even if a method meets the validation criteria required, it is possible that its performance may not be adequate for its application in conformity assessment. Thus, the aim of this project is to establish procedures for the performance evaluation of analytical methods based on measurement uncertainty and using the concepts of Analytical Quality by Design (AQbD) in order to propose improvement strategies. First, the measurement uncertainties associated with analytical methods will be estimated based on the results of validation (accuracy and precision). The consumer's and producer's risks will be estimated using Monte Carlo simulations, for the Bayesian approach, and, additionally, will be estimated by the frequentist approach. One of the analytical methods presenting unsatisfactory performance will have their individual uncertainty sources identified and quantified for AQbD application. We hope that this project will enable the development of tools for evaluate and improve the performance of analytical methods used on conformity assessment of medicines. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
SEPAROVIC, LUCIANA; BETTENCOURT DA SILVA, RICARDO J. N.; LOURENCO, FELIPE REBELLO. Determination of intrinsic and metrological components of the correlation of multiparameter products for minimising the risks of false conformity decisions. MEASUREMENT, v. 180, AUG 2021. Web of Science Citations: 0.
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. Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses - A Review. CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY, JUN 2021. Web of Science Citations: 0.
SEPAROVIC, LUCIANA; LOURENCO, FELIPE REBELLO. Frequentist approach for estimation of false decision risks in conformity assessment based on measurement uncertainty of liquid chromatography analytical procedures. Journal of Pharmaceutical and Biomedical Analysis, v. 184, MAY 30 2020. Web of Science Citations: 0.

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