The system of secondary reference standards in drug quality control laboratories
Pharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary...
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| Format: | Article |
| Language: | Russian |
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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 |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/15 |
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| _version_ | 1849395095512547328 |
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| author | D. A. Leontiev |
| author_facet | D. A. Leontiev |
| author_sort | D. A. Leontiev |
| collection | DOAJ |
| description | Pharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary reference standards (SRS) of a facility. The article describes the experience in the development and implementation of the SRS system in Ukraine within the transition to a two-level system. |
| format | Article |
| id | doaj-art-41338d810fea4d12877d2c00e4eb9b25 |
| 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-41338d810fea4d12877d2c00e4eb9b252025-08-20T03:39:45ZrusFederal 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 средств3034-30623034-34532018-02-0101505513The system of secondary reference standards in drug quality control laboratoriesD. A. Leontiev0Ukrainian Scientific Pharmacopoeial Center for Quality of MedicinesPharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary reference standards (SRS) of a facility. The article describes the experience in the development and implementation of the SRS system in Ukraine within the transition to a two-level system.https://www.vedomostincesmp.ru/jour/article/view/15стандартные образцыанализ лекарственных средствсистема вторичных стандартных образцов предприятияreference standardsquality control of medicinesthe system of secondary reference standards of a facility |
| spellingShingle | D. A. Leontiev The system of secondary reference standards in drug quality control laboratories Регуляторные исследования и экспертиза лекарственных средств стандартные образцы анализ лекарственных средств система вторичных стандартных образцов предприятия reference standards quality control of medicines the system of secondary reference standards of a facility |
| title | The system of secondary reference standards in drug quality control laboratories |
| title_full | The system of secondary reference standards in drug quality control laboratories |
| title_fullStr | The system of secondary reference standards in drug quality control laboratories |
| title_full_unstemmed | The system of secondary reference standards in drug quality control laboratories |
| title_short | The system of secondary reference standards in drug quality control laboratories |
| title_sort | system of secondary reference standards in drug quality control laboratories |
| topic | стандартные образцы анализ лекарственных средств система вторичных стандартных образцов предприятия reference standards quality control of medicines the system of secondary reference standards of a facility |
| url | https://www.vedomostincesmp.ru/jour/article/view/15 |
| work_keys_str_mv | AT daleontiev thesystemofsecondaryreferencestandardsindrugqualitycontrollaboratories AT daleontiev systemofsecondaryreferencestandardsindrugqualitycontrollaboratories |