Design of preclinical studies of biomedical cell products: characteristics, key principles and requirements

Design of preclinical studies of biomedical cell products: characteristics, key principles and requirements

According to the Federal Law «On Biomedical Cell Products», preclinical trials are an integral part of biomedical cell product (BCP) development. This article describes the basic principles of fulfilling requirements laid down in the Rules for conducting preclinical trials of BCPs. The main objectiv...

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Bibliographic Details
Main Authors: E. V. Melnikova, O. V. Merkulova, A. A. Chaplenko, V. A. Merkulov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
доклинические исследования
биомедицинские клеточные продукты
релевантные модели
модели заболеваний
эффективность
оптимальная доза
биораспределение
токсикологические исследования
preclinical studies
biomedical cell products
relevant models
disease models
efficacy
optimal dose
biodistribution
toxicity studies
Online Access:https://www.biopreparations.ru/jour/article/view/95
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