Metrological aspects of expert evaluation of medicinal products’ quality

Abstract

The authors of the article analysed the terms «measurement uncertainty» and «measurement error» and highlighted the main differences between them. They also analysed approaches to the assessment and expression of the measurement uncertainty that are described in the State Pharmacopoeia of the Russia, XIII edition, and guidelines of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. The article reviews basic requirements for reporting assay results as stipulated in the guidelines of the Network of Official Medicines Control Laboratories of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe.

Keywords

• неопределенность измерений
• погрешность измерений
• оценка результатов испытаний
• количественное определение
• экспертиза качества
• measurement uncertainty
• measurement error
• assessment of test results
• assay
• evaluation of quality