Metrological aspects of expert evaluation of medicinal products’ quality
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...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/145 |
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| _version_ | 1849393913439191040 |
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| author | A. A. Turundaeva Yu. V. Olefir A. I. Lutseva N. N. Gromova E. A. Mamashina |
| author_facet | A. A. Turundaeva Yu. V. Olefir A. I. Lutseva N. N. Gromova E. A. Mamashina |
| author_sort | A. A. Turundaeva |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-fa255f03f5ff4bcc8f7587cd9a3428ec |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-fa255f03f5ff4bcc8f7587cd9a3428ec2025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0174228232143Metrological aspects of expert evaluation of medicinal products’ qualityA. A. Turundaeva0Yu. V. Olefir1A. I. Lutseva2N. N. Gromova3E. A. Mamashina4Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe 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.https://www.vedomostincesmp.ru/jour/article/view/145неопределенность измеренийпогрешность измеренийоценка результатов испытанийколичественное определениеэкспертиза качестваmeasurement uncertaintymeasurement errorassessment of test resultsassayevaluation of quality |
| spellingShingle | A. A. Turundaeva Yu. V. Olefir A. I. Lutseva N. N. Gromova E. A. Mamashina Metrological aspects of expert evaluation of medicinal products’ quality Регуляторные исследования и экспертиза лекарственных средств неопределенность измерений погрешность измерений оценка результатов испытаний количественное определение экспертиза качества measurement uncertainty measurement error assessment of test results assay evaluation of quality |
| title | Metrological aspects of expert evaluation of medicinal products’ quality |
| title_full | Metrological aspects of expert evaluation of medicinal products’ quality |
| title_fullStr | Metrological aspects of expert evaluation of medicinal products’ quality |
| title_full_unstemmed | Metrological aspects of expert evaluation of medicinal products’ quality |
| title_short | Metrological aspects of expert evaluation of medicinal products’ quality |
| title_sort | metrological aspects of expert evaluation of medicinal products quality |
| topic | неопределенность измерений погрешность измерений оценка результатов испытаний количественное определение экспертиза качества measurement uncertainty measurement error assessment of test results assay evaluation of quality |
| url | https://www.vedomostincesmp.ru/jour/article/view/145 |
| work_keys_str_mv | AT aaturundaeva metrologicalaspectsofexpertevaluationofmedicinalproductsquality AT yuvolefir metrologicalaspectsofexpertevaluationofmedicinalproductsquality AT ailutseva metrologicalaspectsofexpertevaluationofmedicinalproductsquality AT nngromova metrologicalaspectsofexpertevaluationofmedicinalproductsquality AT eamamashina metrologicalaspectsofexpertevaluationofmedicinalproductsquality |