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: I. N. Tyurenkov, E. M. Lomkina, D. V. Kurkin, D. A. Bakulin, E. V. Volotova
Format: Article
Language:Russian
Published: 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
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