antibioticsАнтибиотики и ХимиотерапияAntibiot Khimioter = Antibiotics and Chemotherapy0235-2990ООО «Издательство ОКИ»10.37489/0235-2990-2020-65-9-10-51-63antibiotics-766Research ArticleСТАНДАРТИЗАЦИЯ И КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВDRUG STANDARDIZATION AND QUALITY CONTROLОсобенности проведения доклинических исследований препаратов клеточной терапииFeatures of Preclinical Studies of Cell Therapy ProductsМельниковаЕ. В.MelnikovaE. V.

Кандидат биологических наук, начальник лаборатории биомедицинских клеточных продуктов ИЦЭКЛС

Москва 

MelnikovaEV@expmed.ruХорольскийМ. Д.KhorolskyM. D.

Инженер-лаборант лаборатории биомедицинских клеточных продуктов ИЦЭКЛС

Москва 

 

РачинскаяО. А.RachinskayaO. A.

Кандидат биологических наук, ведущий эксперт лаборатории биомедицинских клеточных продуктов ИЦЭКЛС

Москва 

МеркуловВ. А.MerkulovV. A.

Доктор медицинских наук, профессор, заместитель генерального директора

Москва 

ФГБУ «Научный центр экспертизы средств медицинского применения» МЗ РФРоссияScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian FederationRussian Federation202031122020659-105163Copyright © Мельникова Е.В., Хорольский М.Д., Рачинская О.А., Меркулов В.А., 20202020Мельникова Е.В., Хорольский М.Д., Рачинская О.А., Меркулов В.А.Melnikova E.V., Khorolsky M.D., Rachinskaya O.A., Merkulov V.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.antibiotics-chemotherapy.ru/jour/article/view/766

Доклинические исследования являются одним из важнейших этапов разработки препаратов для медицинского применения, в том числе препаратов клеточной терапии (в соответствии с законодательством Российской Федерации — биомедицинских клеточных продуктов), на основании результатов изучения специфической активности и безопасности которых регуляторные органы принимают решение о возможности проведения клинических исследований с целью вывода их на рынок. Национальные требования к проведению доклинических исследований препаратов клеточной терапии в целом соответствуют зарубежным, основным отличием является необходимость расширенной программы их проведения. В статье проанализированы аспекты доклинических исследований (объём, обоснование сокращённой программы, дизайн, используемые модели животных) некоторых препаратов клеточной терапии, разрешённых к применению в медицинской практике в США, Европейском союзе, Японии, Южной Кореи.

Preclinical studies are one of the most important stages in the development of drugs for medical use, including cell therapy products (in accordance with the legislation of the Russian Federation — biomedical cell products). Regulatory authorities decide on the possibility of conducting clinical trials in order to bring the medications to the market on the basis of the results of the study of their specific activity and safety. Russian requirements for preclinical studies of cell therapy products generally correspond to foreign ones, the main difference is the need for an expanded program of their conduct. The article analyzes the aspects of preclinical studies (scope, justification of the reduced program, design, animal models used) of some cell therapy products approved for use in medical practice in the United States, the European Union, Japan, and South Korea.

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