The 16 references in paper A. Tikhomirova V., D. Goryachev V., V. Merkulov A., I. Lysikova V., A. Gubenko I., A. Zebrev I., А. Solovieva P., D. Romodanovsky P., E. Melnikova V., А. Тихомирова В., Д. Горячев В., В. Меркулов А., И. Лысикова В., А. Губенко И., А. Зебрев И., А. Соловьева П., Д. Ромодановский П., Д. Мельникова В. (2018) “ДОКЛИНИЧЕСКИЕ И КЛИНИЧЕСКИЕ АСПЕКТЫ РАЗРАБОТКИ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ // PRECLINICAL AND CLINICAL ASPECTS OF THE DEVELOPMENT OF BIOMEDICAL CELL PRODUCTS” / spz:neicon:vedomostincesmp:y:2018:i:1:p:23-35

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Human cells, tissues, and cellular and tissue-based products. 21CFR1271. U.S. Departament of Health and Human Services. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1
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Супотницкий МВ, Елапов АА, Борисевич ИВ, Климов ВИ, Лебединская ЕВ, Миронов АН и др. Перспективные методические подходы к доклиническому исследованию биомедицинских клеточных продуктов и возможные показатели их качества. БИОпрепараты. Профилактика, диагностика, лечение 2015; (1): 36–44. [Supotnitsky MV, Elapov AA, Borisevich IV, Klimov VI, Lebedinskaya EV, Mironov AN, et al. Promising methodological approaches to preclinical studies of biomedical cell-based products and their possible quality characteristics. Biopreparations. Prevention, diagnosis, treatment 2015; (1): 36–44 (In Russ.)]
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Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee. London, 08 April 2010 (EMA/CAT/CPWP/568181/2009). European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2010/05/WC500090887.pdf
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Cellular, Tissue and Gene Therapies Advisory Commit Rel Links. U.S. Departament of Health and Human Services. Available from: https:// www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesA dvisoryCommittee/default.htm
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Пятигорская НВ, Тулина МА, Аладышева ЖИ, Береговых ВВ. Международные подходы к регулированию препаратов клеточной терапии. Вестник Российской академии медицинских наук 2013; 68(8): 4–8. [Pyatigorskaya NV, Tulina MA, Aladysheva ZhI, Beregovykh VV. International approaches to the regulation of cell therapy products. Annals of the Russian academy of medical sciences 2013; 68(8): 4–8 (In Russ.)]
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Ткачук ВА. Методические рекомендации по проведению доклинических исследований биомедицинских клеточных продуктов. М.: МГУ им. Ломоносова; 2017. [Tkachuk VA. Methodical recommendations for conducting preclinical studies of biomedical cellular products. Moscow: Lomonosov Moscow State University; 2017 (In Russ.)]
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Мельникова ЕВ, Меркулова ОВ, Чапленко АА, Меркулов ВА. Дизайн доклинических исследований БМКП: особенности, ключевые принципы и требования. Биопрепараты. Профилак17. Lewis AM Jr. Regulatory implications of neoplastic cell substrate tumorigenicity. U.S. Food and Drug Administration 2005; 31. Available from: http://slideplayer.com/slide/5673889 18. ClinicalTrials.gov. Available from: https://www.clinicaltrials.gov/ct2/ home 19. Федеральный закон Российской Федерации от 23 июня 2016 г. No 180-ФЗ «О биомедицинских клеточных продуктах». [Federal Law of the Russian Federation of 23.06.2016, No. 180-FZ «On Biomedical Cell Products» (In Russ.)] Available from: https://rg.ru/2016/06/28/produkti-dok.html 20. Постановление Правительства РФ
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Приказ Министерства здравоохранения Российской Федерации от 22 сентября 2017 г. No 669н «Об утверждении Правил надлежащей клинической практики биомедицинских клеточных продуктов». [Order of the Ministry of Health of the Russian Federation of 22.09.2017
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