PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS
The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of experimental research. The ar...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
NEICON ISP LLC
2018-03-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/153 |
| _version_ | 1797199095526326272 |
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| author | A. V. Tikhomirova D. V. Goryachev V. A. Merkulov I. V. Lysikova A. I. Gubenko A. I. Zebrev А. P. Solovieva D. P. Romodanovsky E. V. Melnikova |
| author_facet | A. V. Tikhomirova D. V. Goryachev V. A. Merkulov I. V. Lysikova A. I. Gubenko A. I. Zebrev А. P. Solovieva D. P. Romodanovsky E. V. Melnikova |
| author_sort | A. V. Tikhomirova |
| collection | DOAJ |
| description | The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of experimental research. The article describes main characteristics of BCPs approved in the Russian Federation, as well as specific aspects of their formulation and use. It analyses the main stages of preclinical studies (requirements for animal models, testing of general toxicity, immunogenicity, oncogenicity, tumorigenicity, etc.) that do not cover medicine quality evaluation. The article also dwells upon requirements for the clinical stage of BCPs development. It was shown that the choice of clinically relevant efficacy and safety endpoints could be substantiated by respective preclinical data and accumulated experience of the clinical use of medicines for a particular condition. |
| first_indexed | 2024-03-07T19:18:37Z |
| format | Article |
| id | doaj.art-f9be873918494bd6960fb4e34152ae0c |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:10:18Z |
| publishDate | 2018-03-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-f9be873918494bd6960fb4e34152ae0c2024-04-21T11:46:33ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-03-0181233510.30895/1991-2919-2018-8-1-23-35151PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTSA. V. Tikhomirova0D. V. Goryachev1V. A. Merkulov2I. V. Lysikova3A. I. Gubenko4A. I. Zebrev5А. P. Solovieva6D. P. Romodanovsky7E. V. Melnikova8Federal 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 article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of experimental research. The article describes main characteristics of BCPs approved in the Russian Federation, as well as specific aspects of their formulation and use. It analyses the main stages of preclinical studies (requirements for animal models, testing of general toxicity, immunogenicity, oncogenicity, tumorigenicity, etc.) that do not cover medicine quality evaluation. The article also dwells upon requirements for the clinical stage of BCPs development. It was shown that the choice of clinically relevant efficacy and safety endpoints could be substantiated by respective preclinical data and accumulated experience of the clinical use of medicines for a particular condition.https://www.vedomostincesmp.ru/jour/article/view/153biomedical cell productcell linepreclinical studiesclinical trialsspecific mechanism of actionefficacy and safety |
| spellingShingle | A. V. Tikhomirova D. V. Goryachev V. A. Merkulov I. V. Lysikova A. I. Gubenko A. I. Zebrev А. P. Solovieva D. P. Romodanovsky E. V. Melnikova PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS Ведомости Научного центра экспертизы средств медицинского применения biomedical cell product cell line preclinical studies clinical trials specific mechanism of action efficacy and safety |
| title | PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS |
| title_full | PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS |
| title_fullStr | PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS |
| title_full_unstemmed | PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS |
| title_short | PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS |
| title_sort | preclinical and clinical aspects of the development of biomedical cell products |
| topic | biomedical cell product cell line preclinical studies clinical trials specific mechanism of action efficacy and safety |
| url | https://www.vedomostincesmp.ru/jour/article/view/153 |
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