NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT
Expansion of the range of new medicines leads to a significant increase in healthcare spending and, consequently, to the appearance of more affordable generic drugs. A drug can be recognised as generic if there is sufficient evidence of equivalent structural characteristics of the active substance 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’)
2018-03-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/151 |
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| author | D. V. Goryachev Yu. V. Chernova N. E. Uvarova |
| author_facet | D. V. Goryachev Yu. V. Chernova N. E. Uvarova |
| author_sort | D. V. Goryachev |
| collection | DOAJ |
| description | Expansion of the range of new medicines leads to a significant increase in healthcare spending and, consequently, to the appearance of more affordable generic drugs. A drug can be recognised as generic if there is sufficient evidence of equivalent structural characteristics of the active substance and therapeutic characteristics of the drug. However, for a number of substances which are multicomponent mixtures of sister compounds it is quite difficult to demonstrate absolute similarity of the chemical structure and to determine a substrate for bioavailability evaluation. Therefore, a separate group of non-biological complex drugs has been singled out. The present article summarises the requirements of the leading regulatory agencies for demonstration of equivalence between the reference product and such medicines as glatiramoids, liposome-encapsulated doxorubicin and iron-based nanosized colloidal products. It has been shown that preclinical and clinical studies are still necessary for these types of products, and the amount of testing will depend on the results of comparability assessment. |
| format | Article |
| id | doaj-art-afed547b53794c43907842c8f1db5bbc |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-03-01 |
| 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-afed547b53794c43907842c8f1db5bbc2025-08-20T03:57:31ZrusFederal 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 средств3034-30623034-34532018-03-0181111610.30895/1991-2919-2018-8-1-11-16149NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENTD. V. Goryachev0Yu. V. Chernova1N. E. Uvarova2Federal 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 FederationExpansion of the range of new medicines leads to a significant increase in healthcare spending and, consequently, to the appearance of more affordable generic drugs. A drug can be recognised as generic if there is sufficient evidence of equivalent structural characteristics of the active substance and therapeutic characteristics of the drug. However, for a number of substances which are multicomponent mixtures of sister compounds it is quite difficult to demonstrate absolute similarity of the chemical structure and to determine a substrate for bioavailability evaluation. Therefore, a separate group of non-biological complex drugs has been singled out. The present article summarises the requirements of the leading regulatory agencies for demonstration of equivalence between the reference product and such medicines as glatiramoids, liposome-encapsulated doxorubicin and iron-based nanosized colloidal products. It has been shown that preclinical and clinical studies are still necessary for these types of products, and the amount of testing will depend on the results of comparability assessment.https://www.vedomostincesmp.ru/jour/article/view/151generic drugsnon-biological complex drugsglatiramoidsiron-based nano-sized colloidal productsliposome-encapsulated doxorubicinpreclinical and clinical trials |
| spellingShingle | D. V. Goryachev Yu. V. Chernova N. E. Uvarova NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT Регуляторные исследования и экспертиза лекарственных средств generic drugs non-biological complex drugs glatiramoids iron-based nano-sized colloidal products liposome-encapsulated doxorubicin preclinical and clinical trials |
| title | NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT |
| title_full | NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT |
| title_fullStr | NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT |
| title_full_unstemmed | NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT |
| title_short | NON-BIOLOGICAL COMPLEX DRUGS CONCEPT IN GENERIC DRUGS DEVELOPMENT |
| title_sort | non biological complex drugs concept in generic drugs development |
| topic | generic drugs non-biological complex drugs glatiramoids iron-based nano-sized colloidal products liposome-encapsulated doxorubicin preclinical and clinical trials |
| url | https://www.vedomostincesmp.ru/jour/article/view/151 |
| work_keys_str_mv | AT dvgoryachev nonbiologicalcomplexdrugsconceptingenericdrugsdevelopment AT yuvchernova nonbiologicalcomplexdrugsconceptingenericdrugsdevelopment AT neuvarova nonbiologicalcomplexdrugsconceptingenericdrugsdevelopment |