Setting multivariate and correlated acceptance limits for assessing the conformity of items

RJN Bettencourt da Silva, F Lourenço… - Analytical Letters, 2022 - Taylor & Francis
Many industrial products, foodstuffs and environmental samples are checked for values of
different chemical parameters against tolerance limits or intervals defined in a specification …

IUPAC/CITAC Guide: Evaluation of risks of false decisions in conformity assessment of a substance or material with a mass balance constraint (IUPAC Technical …

FR Pennecchi, I Kuselman, DB Hibbert - Pure and Applied Chemistry, 2023 - degruyter.com
A Bayesian multivariate approach to the evaluation of risks of false decisions on conformity
of chemical composition of a substance or material due to measurement uncertainty is …

Definition of multivariate acceptance limits (guard-bands) applied to pharmaceutical equivalence assessment

CM da Silva, FR Lourenço - Journal of Pharmaceutical and Biomedical …, 2023 - Elsevier
The quality assessment of medicines involves multiple compliance parameters, such as
identity, dosage, purity, potency, content uniformity, disintegration time, dissolution rate …

Conformity assessment of medicines containing antibiotics–A multivariate assessment

M Lombardo, CM da Silva, FR Lourenço - Regulatory Toxicology and …, 2022 - Elsevier
Pharmaceutical products must meet quality requirements to ensure the efficacy and safety of
pharmacological treatment. Non-compliance of medicines can cause economic losses and …

[HTML][HTML] Risk of false conformity assessment applied to automotive fuel analysis: A multiparameter approach

EC de Oliveira, FR Lourenço - Chemosphere, 2021 - Elsevier
The low-quality of automotive fuels may lead to the generation of pollutants harmful to both
environmental and human health. The quality evaluation of automotive fuels requires a …

Risk of false conformity decisions of multicomponent items controlled by correlated measurement results due to the sharing of analytical steps

FR Lourenco, RJNB da Silva - Talanta, 2019 - Elsevier
The assessment of the conformity of some items, such as medicines, food products or
drinking waters, with limits set for several of their components, involves the determination of …

IUPAC/CITAC Guide: Evaluation of risks of false decisions in conformity assessment of a multicomponent material or object due to measurement uncertainty (IUPAC …

I Kuselman, FR Pennecchi, RJNB da Silva… - Pure and Applied …, 2021 - degruyter.com
Risks of a false decision on conformity of the chemical composition of a multicomponent
material or object due to measurement uncertainty are defined using the Bayesian …

Risk of a false decision on conformity of an environmental compartment due to measurement uncertainty of concentrations of two or more pollutants

FR Pennecchi, I Kuselman, RJNB da Silva, DB Hibbert - Chemosphere, 2018 - Elsevier
Risks of false decisions in conformity assessment of an environmental compartment due to
measurement uncertainty of concentrations of two or more pollutants are discussed. Even if …

Spreadsheet for evaluation of global risks in conformity assessment of a multicomponent material or object

RJNB da Silva, FR Lourenço, FR Pennecchi… - Chemometrics and …, 2019 - Elsevier
A user-friendly MS-Excel spreadsheet is developed for evaluation of global consumer's and
producer's risks in conformity assessment of chemical composition of a multicomponent …

Measurement uncertainty arising from sampling and analytical steps of dissolution test of prednisone tablets

AY Sano, FR Lourenço - Journal of Pharmaceutical and Biomedical …, 2023 - Elsevier
Dissolution is used to determine the rate and extent of drug release from the dosage form
into a dissolution medium, which allow to assess the batch-to-batch variability. Considering …