Recommendations on the procedure for determining the interchangeability of medicinal products
The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for a...
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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/31 |
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| author | B. K. Romanov N. D. Bunyatyan Yu. V. Olefir V. P. Bondarev A. B. Prokofyev R. I. Yagudina R. N. Alyautdin E. L. Kovaleva A. P. Pereverzev K. E. Zatolochina A. S. Kazakov A. V. Komratov E. Yu. Pasternak |
| author_facet | B. K. Romanov N. D. Bunyatyan Yu. V. Olefir V. P. Bondarev A. B. Prokofyev R. I. Yagudina R. N. Alyautdin E. L. Kovaleva A. P. Pereverzev K. E. Zatolochina A. S. Kazakov A. V. Komratov E. Yu. Pasternak |
| author_sort | B. K. Romanov |
| collection | DOAJ |
| description | The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»). |
| format | Article |
| id | doaj-art-d347dfd34ffb48b390bf87af9c35c7f4 |
| 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-d347dfd34ffb48b390bf87af9c35c7f42025-08-20T03:57:31ZrusFederal 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 средств3034-30623034-34532018-02-01023829Recommendations on the procedure for determining the interchangeability of medicinal productsB. K. Romanov0N. D. Bunyatyan1Yu. V. Olefir2V. P. Bondarev3A. B. Prokofyev4R. I. Yagudina5R. N. Alyautdin6E. L. Kovaleva7A. P. Pereverzev8K. E. Zatolochina9A. S. Kazakov10A. V. Komratov11E. Yu. Pasternak12Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»).https://www.vedomostincesmp.ru/jour/article/view/31рекомендациивзаимозаменяемостьлекарственное средствобиоэквивалентностьтерапевтическая эквивалентностьrecommendationinterchangeabilitymedicinal productbioequivalencetherapeutic equivalence |
| spellingShingle | B. K. Romanov N. D. Bunyatyan Yu. V. Olefir V. P. Bondarev A. B. Prokofyev R. I. Yagudina R. N. Alyautdin E. L. Kovaleva A. P. Pereverzev K. E. Zatolochina A. S. Kazakov A. V. Komratov E. Yu. Pasternak Recommendations on the procedure for determining the interchangeability of medicinal products Регуляторные исследования и экспертиза лекарственных средств рекомендации взаимозаменяемость лекарственное средство биоэквивалентность терапевтическая эквивалентность recommendation interchangeability medicinal product bioequivalence therapeutic equivalence |
| title | Recommendations on the procedure for determining the interchangeability of medicinal products |
| title_full | Recommendations on the procedure for determining the interchangeability of medicinal products |
| title_fullStr | Recommendations on the procedure for determining the interchangeability of medicinal products |
| title_full_unstemmed | Recommendations on the procedure for determining the interchangeability of medicinal products |
| title_short | Recommendations on the procedure for determining the interchangeability of medicinal products |
| title_sort | recommendations on the procedure for determining the interchangeability of medicinal products |
| topic | рекомендации взаимозаменяемость лекарственное средство биоэквивалентность терапевтическая эквивалентность recommendation interchangeability medicinal product bioequivalence therapeutic equivalence |
| url | https://www.vedomostincesmp.ru/jour/article/view/31 |
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