Impact of sampling and analytical uncertainties on conformity assessment of pharmaceutical products

• Grant number: 22/08406-5
• Support Opportunities: Regular Research Grants
• Start date: November 01, 2022
• End date: October 31, 2024
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Felipe Rebello Lourenço
• Grantee: Felipe Rebello Lourenço
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

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 will study the impact of sampling and analytical uncertainties on conformity assessment of pharmaceutical products. The measurement uncertainty arising from sampling will be assess using simulations methods (such as Monte Carlo and Bootstrapping methods) and/or by experimental determination of sample heterogeneity. Analytical measurement uncertainty will be assess using top-down and/or bottom-up approaches. The impact of sampling and analytical measurement uncertainty on conformity assessment will be studied be determining the risk of false conformity decisions and/or applying the guard band concepts. Where relevant, strategies will be proposed to reduce uncertainty, whether associated with sampling or the analytical stage, in order to ensure appropriate final uncertainty values for use. The project also aims to establish the procedures for estimating the risk of false decisions in situations where asymmetric distribution is expected. (AU)

Scientific publications

(5)

(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)

COUTO, ALDO RENATO; SILVA PASSARIN, PAULA BEATRIZ; LOURENCO, FELIPE R.. Risk of false conformity decisions in LAL gel-clot test due to false-negative results. CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, v. 234, p. 6-pg., 2023-01-18. (22/08406-5)

ROCHA, ARIEL LUCAS; LOURENCO, FELIPE REBELLO. Development and optimization of a LC-MS/MS compatible method for quantification of losartan, hydrochlorothiazide and their impurities using AQbD approach and measurement uncertainty evaluation. Talanta, v. 259, p. 14-pg., 2023-03-28. (22/08406-5)

GUSTAVO KENJI TOKO PURCINO DO AMARAL; FELIPE REBELLO LOURENÇO. Risk of false conformity decisions due to measurement uncertainty of Active Pharmaceutical Ingredient: A multiparametric evaluation. Brazilian Journal of Pharmaceutical Sciences, v. 60, 2024-02-26. (22/08406-5)

SANO, ADRIANO Y.; LOURENCO, FELIPE R.. Measurement uncertainty arising from sampling and analytical steps of dissolution test of prednisone tablets. Journal of Pharmaceutical and Biomedical Analysis, v. 234, p. 7-pg., 2023-06-20. (22/08406-5)

CINTIA MARGUEIRO DA SILVA; FELIPE REBELLO LOURENÇO. Multivariate guard-bands and total risk assessment on multiparameter evaluations with correlated and uncorrelated measured values. Brazilian Journal of Pharmaceutical Sciences, v. 60, 2024-02-26. (22/08406-5)