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

• Grant number: 19/16206-3
• Support Opportunities: Regular Research Grants
• Start date: March 01, 2020
• End date: February 28, 2022
• 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

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)

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)

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. (19/16206-3)

DE GODOY BERTANHA, MARIA LUIZA; LOURENCO, FELIPE REBELLO. Risk of false decisions in chromatographic and spectrometric identification of chemical compounds. MEASUREMENT, v. 183, OCT 2021. (19/16206-3)

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. (19/16206-3, 17/04539-2)

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. (18/25734-0, 19/15549-4, 19/16206-3)

SIMABUKURO, RENAN; JEONG, NOH AH; LOURENCO, FELIPE REBELLO. Application of Measurement Uncertainty on Conformity Assessment in Pharmaceutical Drug Products. JOURNAL OF AOAC INTERNATIONAL, v. 104, n. 3, p. 585-591, MAY-JUN 2021. (19/16206-3)

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. (19/16206-3)

BERTANHA, MARIA LUIZA DE GODOY; LOURENCO, FELIPE REBELLO. Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty. Journal of Pharmaceutical and Biomedical Analysis, v. 204, SEP 10 2021. (19/16206-3)

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, v. 53, n. 1, p. 16-pg., 2021-06-08. (19/16206-3, 18/25734-0, 19/15549-4)

COUTO, ALDO RENATO; LOURENCO, FELIPE REBELLO. Definition of medicine shelf-life based on the assessment of the total risk of false conformity decisions due to measurement uncertainty-A multiparameter approach. CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, v. 229, p. 12-pg., 2022-09-05. (19/16206-3)