دورية أكاديمية
RISK ASSESSMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS
| العنوان: | RISK ASSESSMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS |
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| المؤلفون: | R. N. Alyautdin, B. K. Romanov, A. N. Yavorsky, N. D. Bunyatyan, V. A. Merkulov, A. N. Mironov |
| المصدر: | Безопасность и риск фармакотерапии, Vol 0, Iss 1, Pp 7-12 (2018) |
| بيانات النشر: | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018. |
| سنة النشر: | 2018 |
| المجموعة: | LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | средства передовой терапии, нежелательные реакции, факторы риска, advanced therapy, medicinal products, adverse reactions, risk factors, Therapeutics. Pharmacology, RM1-950 |
| الوصف: | Advanced therapy medicinal products (ATMP) represent a heterogeneous group of medicinal products, combined with the need for special regulation of their circulation. ATMP is a gene therapy medicinal products, a somatic cell therapy medicinal products, a tissue engineered products and combined ATMPs. The regulatory framework for ATMPs is established by Regulation (EC) No 1394/2007 on ATMPs which is designed to ensure the free movement of these medicines. The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) was established in accordance with the Advanced Therapies Regulation as a multidisciplinary committee, whose primary responsibility is to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field. Since June 2009 the CAT issues scientific recommendations on ATMPs classification. CAT defines the strategy for the identification and analysis of risks associated with the clinical application of ATMP and risk factors determined by the quality of the product and the ratio of benefit-risk. The article presents methods of analysis of risk factors in the study of ATMP. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | Russian |
| تدمد: | 2312-7821 2619-1164 |
| Relation: | https://www.risksafety.ru/jour/article/view/3; https://doaj.org/toc/2312-7821; https://doaj.org/toc/2619-1164 |
| URL الوصول: | https://doaj.org/article/fb5feca2af454a389c472a4cd2c8666a |
| رقم الأكسشن: | edsdoj.fb5feca2af454a389c472a4cd2c8666a |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 23127821 26191164 |
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