Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation
Analysis of XI and XII editions of the State Pharmacopoeia of the Russian Federation proved the necessity and relevance of elaborating quality standards for immunobiological medicinal products as well as methods of their control. Assurance of safety and efficacy of this group of medicines could be a...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/78 |
| _version_ | 1797199060481867776 |
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| author | A. A. Movsesyants V. P. Bondarev Yu. V. Olefir V. A. Merkulov L. F. Shimchuk |
| author_facet | A. A. Movsesyants V. P. Bondarev Yu. V. Olefir V. A. Merkulov L. F. Shimchuk |
| author_sort | A. A. Movsesyants |
| collection | DOAJ |
| description | Analysis of XI and XII editions of the State Pharmacopoeia of the Russian Federation proved the necessity and relevance of elaborating quality standards for immunobiological medicinal products as well as methods of their control. Assurance of safety and efficacy of this group of medicines could be achieved only by fulfilling the requirements of modern standards of quality and assuming that methods used for assessment of quality parameters of biologicals are adequate and informative. Top priorities addressed during the preparation of the XIII edition of the State Pharmacopoeia of the Russian Federation were: systematization of quality standards for biologicals on the basis of product types and methods of analysis, and harmonization of requirements for quality parameters with those of the leading world pharmacopoeias, primarily with the European Pharmacopoeia. |
| first_indexed | 2024-03-07T19:18:06Z |
| format | Article |
| id | doaj.art-70d5b42af26744bc9abe4dbc9ad8dbd7 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:45Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-70d5b42af26744bc9abe4dbc9ad8dbd72024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0102384176Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian FederationA. A. Movsesyants0V. P. Bondarev1Yu. V. Olefir2V. A. Merkulov3L. F. Shimchuk4Scientific 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 ProductsAnalysis of XI and XII editions of the State Pharmacopoeia of the Russian Federation proved the necessity and relevance of elaborating quality standards for immunobiological medicinal products as well as methods of their control. Assurance of safety and efficacy of this group of medicines could be achieved only by fulfilling the requirements of modern standards of quality and assuming that methods used for assessment of quality parameters of biologicals are adequate and informative. Top priorities addressed during the preparation of the XIII edition of the State Pharmacopoeia of the Russian Federation were: systematization of quality standards for biologicals on the basis of product types and methods of analysis, and harmonization of requirements for quality parameters with those of the leading world pharmacopoeias, primarily with the European Pharmacopoeia.https://www.vedomostincesmp.ru/jour/article/view/78иммунобиологические лекарственные препаратыфармакопеястандартизацияimmunobiological medicinal productspharmacopoeiastandardization |
| spellingShingle | A. A. Movsesyants V. P. Bondarev Yu. V. Olefir V. A. Merkulov L. F. Shimchuk Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation Ведомости Научного центра экспертизы средств медицинского применения иммунобиологические лекарственные препараты фармакопея стандартизация immunobiological medicinal products pharmacopoeia standardization |
| title | Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation |
| title_full | Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation |
| title_fullStr | Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation |
| title_full_unstemmed | Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation |
| title_short | Quality standards for immunobiological medicinal products - new texts in the State Pharmacopoeia of the Russian Federation |
| title_sort | quality standards for immunobiological medicinal products new texts in the state pharmacopoeia of the russian federation |
| topic | иммунобиологические лекарственные препараты фармакопея стандартизация immunobiological medicinal products pharmacopoeia standardization |
| url | https://www.vedomostincesmp.ru/jour/article/view/78 |
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