Measurement uncertainty and conformity assessment applied to drug and medicine analyses–a review

L Separovic, RS Simabukuro, AR Couto… - Critical Reviews in …, 2023 - Taylor & Francis
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 …

Analytical quality by design, life cycle management, and method control

T Verch, C Campa, CC Chéry, R Frenkel, T Graul… - The AAPS Journal, 2022 - Springer
Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to
conduct research and development, and to help control manufacturing inputs and outputs …

Experimental methods in chemical engineering: Monte Carlo

E Pahija, S Hwangbo… - … Canadian Journal of …, 2024 - Wiley Online Library
Monte Carlo (MC) methods employ a statistical approach to evaluate complex mathematical
models that lack analytical solutions and assess their uncertainties. To this end, techniques …

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 …

Concept for the valorization of cereal processing waste: Recovery of phenolic acids by using waste-derived tetrahydrofurfuryl alcohol and biochar

W Mikucka, I Witońska, M Zielińska, K Bułkowska… - Chemosphere, 2023 - Elsevier
Valorization of agro-food waste by converting it into a renewable resource plays a crucial
role in a bio-based circular economy. Therefore, this study was designed to evaluate the …

[HTML][HTML] Development, validation, and estimation of measurement uncertainty for the quantitative determination of nitrosamines in Sartan drugs using liquid …

NK Nagendla, H Shaik, SB Subrahanyam… - Journal of …, 2022 - Elsevier
In the current study, a feasible and sensitive liquid chromatography-atmospheric pressure
chemical ionization tandem mass spectrometry (LC-APCI-MS/MS) method was developed …

Measurement uncertainty and risk of false conformity decision in the performance evaluation of liquid chromatography analytical procedures

L Separovic, FR Lourenco - Journal of Pharmaceutical and Biomedical …, 2019 - Elsevier
Liquid chromatography is one of the main techniques used in pharmaceutical quality control
analytical procedures. However, there will always be a measurement uncertainty (MU) …