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Using measurement uncertainty in performance evaluation of analytical methods

Grant number: 17/04539-2
Support type:Regular Research Grants
Duration: September 01, 2017 - February 29, 2020
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal researcher:Felipe Rebello Lourenço
Grantee:Felipe Rebello Lourenço
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

The analytical methods employed in quality control of drugs and cosmetics should be validated according to the criteria set in international guides. However, even if a method meets the defined validation criteria, it is possible that their performance is not good enough for products conformity evaluation. In this way, the goal of this project is to establish procedures for the performance evaluation of analytical methods based on measurement uncertainty. First, the measurement uncertainties associated with analytical methods will be estimated on the basis of validation results (accuracy and precision). The customers' and producers' risks will be estimated using Monte Carlo simulations, considering manufacturing processes with different capability scenarios. The analytical methods that present unsatisfactory performance will have their individual uncertainty sources identified and quantified in order to establish strategies for performance improvement, using the Analytical Quality by Design (AQbD) concepts. We hope that this project will enable the development of tools for assessing the performance of analytical methods usually employed by the pharmaceutical industry on conformity assessment of medicines and cosmetics. (AU)

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Scientific publications (9)
(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)
DIAS, FRANCIELLE REGINA SILVA; LOURENCO, FELIPE REBELLO. Measurement uncertainty evaluation and risk of false conformity assessment for microbial enumeration tests. Journal of Microbiological Methods, v. 189, OCT 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.
DE SANTANA, PATRICIA CRISTINA; LOURENCO, FELIPE REBELLO. A smartphone-based bioassay for determining relative potency estimated from sigmoidal-response curves and respective measurement uncertainty. Microchemical Journal, v. 154, MAY 2020. Web of Science Citations: 1.
SAVIANO, ALESSANDRO MORAIS; LOURENCO, FELIPE REBELLO. Using image analysis to determine gentamicin potency by agar diffusion microbiological assay and its measurement uncertainty. MEASUREMENT, v. 146, p. 315-321, NOV 2019. Web of Science Citations: 0.
SEPAROVIC, LUCIANA; LOURENCO, FELIPE REBELLO. Measurement uncertainty and risk of false conformity decision in the performance evaluation of liquid chromatography analytical procedures. Journal of Pharmaceutical and Biomedical Analysis, v. 171, p. 73-80, JUL 15 2019. Web of Science Citations: 0.
SEPAROVIC, LUCIANA; BETTENCOURT DA SILVA, RICARDO J. N.; LOURENCO, FELIPE REBELLO. Improved spreadsheet method for determination of between components metrological correlation due to the sharing of analytical steps. CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, v. 189, p. 161-168, JUN 15 2019. Web of Science Citations: 0.
LOURENCO, FELIPE R.; BETTENCOURT DA SILVA, RICARDO J. N. Risk of false conformity decisions of multicomponent items controlled by correlated measurement results due to the sharing of analytical steps. Talanta, v. 196, p. 174-181, MAY 1 2019. Web of Science Citations: 3.
SEPAROVIC, LUCIANA; SAVIANO, ALESSANDRO MORAIS; LOURENCO, FELIPE REBELLO. Using measurement uncertainty to assess the fitness for purpose of an HPLC analytical method in the pharmaceutical industry. MEASUREMENT, v. 119, p. 41-45, APR 2018. Web of Science Citations: 5.

Please report errors in scientific publications list by writing to: cdi@fapesp.br.