vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-128Research ArticleДОКЛИНИЧЕСКОЕ И КЛИНИЧЕСКОЕ ИЗУЧЕНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВPRECLINICAL AND CLINICAL STUDY OF MEDICINESМетодические подходы к оценке нейротоксичности фармакологических веществMethodological approaches to the assessment of pharmaceutical substances neurotoxicityМакароваМ. Н.MakarovaM. N.noemail@neicon.ruМакаровВ. Г.MakarovV. G.noemail@neicon.ruШекуноваЕ. В.ShekunovaE. V.noemail@neicon.ruЗакрытое акционерное общество «Научно-производственное объединение «ДОМ ФАРМАЦИИ»РоссияCJSC Scientific-Production Association «HOME OF PHARMACY»Russian Federation20171302201872111116Copyright © Макарова М.Н., Макаров В.Г., Шекунова Е.В., 20182018Макарова М.Н., Макаров В.Г., Шекунова Е.В.Makarova M.N., Makarov V.G., Shekunova E.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/128

В статье рассмотрены методические подходы к оценке нейротоксичности фармакологических веществ. Описана основная батарея тестов на животных, проводимая до начала клинических исследований для оценки влияния препарата на функцию жизненно-важных систем организма. Рассмотрены такие аспекты, как выбор вида животных, выбор дозы и длительность введения фармакологического вещества, проведение клинического обследования, функциональных тестов и гистологических исследований. Отмечено, что правильное обоснование программы исследования может позволить существенно сократить перечень исследований. Обоснована целесообразность использования не менее двух видов животных для оценки нейротоксичности, с обязательным использованием не грызунов, результаты которой позволят в максимально возможном объеме в ходе доклинических исследований изучить профиль безопасности лекарственного препарата и обеспечат необходимый уровень безопасности для человека при переходе на I фазу клинических исследований.

The article reviews methodological approaches to the assessment of pharmaceutical substances neurotoxicity. It describes the main battery of animal tests that are conducted prior to clinical trials in order to assess drug effects on the functioning of vital body systems. The article addresses the choice of animal species, dosage and duration of pharmaceutical substance administration, as well as the conduct of clinical trials, functional tests and histological studies. It points out that an adequate justification of the study programme may help substantially reduce the number of tests. The authors assert the need to use at least two animal species in neurotoxicity studies, one of which must be a non-rodent species, in order to be able to investigate the drug safety profile during preclinical studies in as much detail as possible and to assure the required safety level for people when moving on to Phase I of clinical trials.

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The authors declare that there are no conflicts of interest present.