Ethical implications of preclinical studies
Animal experiments are fundamental for the biomedical science. The development of new drugs is always associated with a large number of preclinical experiments in animals. Experimental data make it possible to predict the drug efficacy and safety in humans. There are more than 100 million laboratory...
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| Main Authors: | , , , , |
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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/51 |
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| author | I. N. Tyurenkov E. M. Lomkina D. V. Kurkin D. A. Bakulin E. V. Volotova |
| author_facet | I. N. Tyurenkov E. M. Lomkina D. V. Kurkin D. A. Bakulin E. V. Volotova |
| author_sort | I. N. Tyurenkov |
| collection | DOAJ |
| description | Animal experiments are fundamental for the biomedical science. The development of new drugs is always associated with a large number of preclinical experiments in animals. Experimental data make it possible to predict the drug efficacy and safety in humans. There are more than 100 million laboratory animals that are used by researchers every year worldwide. This fact raises a number of concerns regarding the legality and ethical appropriateness of using such a large number of animals. This article discusses the problem of using an unreasonably large number of experimental animals during preclinical drug studies, as well as potential ways of streamlining existing methods used for determining the acute and subacute toxicity of drugs in order to minimize the time of the study and the number of animals used. In addition, we review the problem of systematizing experimental data and potential ways of their standardization in line with the European legislation regulating ethically approved use of animals in experiments. |
| format | Article |
| id | doaj-art-902b3dcb3e6a42f6bab4afdfd2725033 |
| 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-902b3dcb3e6a42f6bab4afdfd27250332025-08-20T03:39:45ZrusFederal 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 средств3034-30623034-34532018-02-0103364149Ethical implications of preclinical studiesI. N. Tyurenkov0E. M. Lomkina1D. V. Kurkin2D. A. Bakulin3E. V. Volotova4State Educational Institution of Higher Vocational Training Volgograd Medical University of the Ministry of Health of the Russian FederationState Educational Institution of Higher Vocational Training Volgograd Medical University of the Ministry of Health of the Russian FederationState Educational Institution of Higher Vocational Training Volgograd Medical University of the Ministry of Health of the Russian FederationState Educational Institution of Higher Vocational Training Volgograd Medical University of the Ministry of Health of the Russian FederationState Educational Institution of Higher Vocational Training Volgograd Medical University of the Ministry of Health of the Russian FederationAnimal experiments are fundamental for the biomedical science. The development of new drugs is always associated with a large number of preclinical experiments in animals. Experimental data make it possible to predict the drug efficacy and safety in humans. There are more than 100 million laboratory animals that are used by researchers every year worldwide. This fact raises a number of concerns regarding the legality and ethical appropriateness of using such a large number of animals. This article discusses the problem of using an unreasonably large number of experimental animals during preclinical drug studies, as well as potential ways of streamlining existing methods used for determining the acute and subacute toxicity of drugs in order to minimize the time of the study and the number of animals used. In addition, we review the problem of systematizing experimental data and potential ways of their standardization in line with the European legislation regulating ethically approved use of animals in experiments.https://www.vedomostincesmp.ru/jour/article/view/51доклинические испытанияразработка и поиск новых лекарственных средствострая токсичностьэксперименты на животныхэтическое регулированиеpreclinical trialsdevelopment of new medicinesacute toxicityexperiments on animalsethical regulation |
| spellingShingle | I. N. Tyurenkov E. M. Lomkina D. V. Kurkin D. A. Bakulin E. V. Volotova Ethical implications of preclinical studies Регуляторные исследования и экспертиза лекарственных средств доклинические испытания разработка и поиск новых лекарственных средств острая токсичность эксперименты на животных этическое регулирование preclinical trials development of new medicines acute toxicity experiments on animals ethical regulation |
| title | Ethical implications of preclinical studies |
| title_full | Ethical implications of preclinical studies |
| title_fullStr | Ethical implications of preclinical studies |
| title_full_unstemmed | Ethical implications of preclinical studies |
| title_short | Ethical implications of preclinical studies |
| title_sort | ethical implications of preclinical studies |
| topic | доклинические испытания разработка и поиск новых лекарственных средств острая токсичность эксперименты на животных этическое регулирование preclinical trials development of new medicines acute toxicity experiments on animals ethical regulation |
| url | https://www.vedomostincesmp.ru/jour/article/view/51 |
| work_keys_str_mv | AT intyurenkov ethicalimplicationsofpreclinicalstudies AT emlomkina ethicalimplicationsofpreclinicalstudies AT dvkurkin ethicalimplicationsofpreclinicalstudies AT dabakulin ethicalimplicationsofpreclinicalstudies AT evvolotova ethicalimplicationsofpreclinicalstudies |