Using measurement uncertainty in performance evaluation of analytical methods

• Grant number: 17/04539-2
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2017
• End date: February 29, 2020
• 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 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)

Scientific publications

(10)

(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)

MOREIRA, CAMILA DOS SANTOS; LOURENCO, FELIPE REBELLO. Development and optimization of a stability-indicating chromatographic method for verapamil hydrochloride and its impurities in tablets using an analytical quality by design (AQbD) approach. Microchemical Journal, v. 154, MAY 2020. (17/04539-2)

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. (18/25734-0, 17/04539-2)

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. (17/04539-2)

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. (17/04539-2)

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. (17/04539-2)

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. (17/04539-2)

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. (16/04100-8, 17/04539-2)

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)

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. (17/04539-2)

SEPAROVIC, LUCIANA; LOURENCO, FELIPE REBELLO. Measurement uncertainty evaluation of an analytical procedure for determination of terbinafine hydrochloride in creams by HPLC and optimization strategies using Analytical Quality by Design. Microchemical Journal, v. 178, p. 13-pg., 2022-07-01. (17/04539-2)