Trend analysis of batch to batch consistency during quality assessment of biological medicinal products
The statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’...
| Main Author: | |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/109 |
| _version_ | 1797244518015172608 |
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| author | D. S. Davydov |
| author_facet | D. S. Davydov |
| author_sort | D. S. Davydov |
| collection | DOAJ |
| description | The statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’ quality standards and to ensure the reliability of laboratory tests. The article briefly surveys the positions of the World Health Organization (WHO) and the International Organization for Standardization (ISO) on the analysis of trends in the production of biological medicinal products, especially vaccines, as well as on methodological approaches to the planning and organization of random sampling checks. |
| first_indexed | 2024-03-08T21:44:29Z |
| format | Article |
| id | doaj.art-d96c9da1e173472dbb5566661153addc |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:17Z |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-d96c9da1e173472dbb5566661153addc2024-03-26T09:10:52ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-01174230232109Trend analysis of batch to batch consistency during quality assessment of biological medicinal productsD. S. Davydov0Scientific Centre for Expert Evaluation of Medicinal ProductsThe statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’ quality standards and to ensure the reliability of laboratory tests. The article briefly surveys the positions of the World Health Organization (WHO) and the International Organization for Standardization (ISO) on the analysis of trends in the production of biological medicinal products, especially vaccines, as well as on methodological approaches to the planning and organization of random sampling checks.https://www.biopreparations.ru/jour/article/view/109управление качествомбиологические лекарственные препаратывакциныподтверждение соответствияконтрольные картыquality managementbiological medicinal productsvaccinesconformity assessmentcontrol charts |
| spellingShingle | D. S. Davydov Trend analysis of batch to batch consistency during quality assessment of biological medicinal products Биопрепараты: Профилактика, диагностика, лечение управление качеством биологические лекарственные препараты вакцины подтверждение соответствия контрольные карты quality management biological medicinal products vaccines conformity assessment control charts |
| title | Trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| title_full | Trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| title_fullStr | Trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| title_full_unstemmed | Trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| title_short | Trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| title_sort | trend analysis of batch to batch consistency during quality assessment of biological medicinal products |
| topic | управление качеством биологические лекарственные препараты вакцины подтверждение соответствия контрольные карты quality management biological medicinal products vaccines conformity assessment control charts |
| url | https://www.biopreparations.ru/jour/article/view/109 |
| work_keys_str_mv | AT dsdavydov trendanalysisofbatchtobatchconsistencyduringqualityassessmentofbiologicalmedicinalproducts |