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Risks of false decisions due to the measurement uncertainties in the evaluation of pharmaceutical equivalence

Grant number: 19/16206-3
Support type:Regular Research Grants
Duration: March 01, 2020 - February 28, 2022
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 pharmaceutical equivalence between test (generic or similar) and reference medicine is evaluated through in vitro quality tests involving multiple compliance parameters. Despite efforts to ensure the reliability of the analytical results obtained in the pharmaceutical equivalence studies, there is a risk of false decisions due to measurement uncertainties. Thus, the objective of this project is to evaluate the measurement uncertainties associated with the analytical results obtained in the pharmaceutical equivalence studies of different pharmaceutical forms, as well as to estimate the risks of false decisions regarding the evaluation of pharmaceutical equivalence. The measurement uncertainties associated with the analytical results will be evaluated using the bottom-up (law of the propagation of uncertainties, Kragten spreadsheet method and/or Monte Carlo method) and top-down (uncertainty obtained from the analytical procedure validation data) approaches. From the uncertainties assessed, the consumers' and producers' risks and the particular and total risks will be estimated using the Monte Carlo method. We hope that this project will allow the development of procedures for estimating the combined particular risks and combined total risk, which would be useful in making decisions regarding the evaluation of pharmaceutical equivalence between the test (generic or similar) and reference medicines. The estimation of the risks of false decisions is of great interest to regulatory bodies and pharmaceutical equivalence centers, particularly for the evaluation of the quality of medicines that are not submitted to bioequivalence studies. (AU)

Articles published in Agência FAPESP Newsletter about the research grant:
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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)
DE OLIVEIRA, ELCIO CRUZ; LOURENCO, FELIPE REBELLO. Risk of false conformity assessment applied to automotive fuel analysis: A multiparameter approach. Chemosphere, v. 263, JAN 2021. Web of Science Citations: 0.
DA SILVA, SARA BERTOLETTI; LOURENCO, FELIPE REBELLO. Risk of false compliance/non-compliance decisions for sterility test due to false-negative and false-positive test results. CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, v. 200, MAY 15 2020. Web of Science Citations: 0.

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