Advanced-Therapy Medicinal Products: Challenges for Implementation in Pediatric Clinical Practice

Y. Gomon, A. Kolbin
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Abstract

The article discusses classifications of medicines for gene and cell therapy. Data on medicinal products registered in Russia, as well as in the European Union countries, Great Britain, USA, and Japan is presented. The limitations on using such medicinal products were considered, including their high utilitarian cost and high risk of adverse events. The potential for increasing clinical efficacy and economic feasibility of advanced therapies (pediatrics included) has been analyzed.
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高级治疗药物产品:儿科临床实践面临的挑战
文章讨论了基因和细胞疗法药物的分类。文章介绍了在俄罗斯、欧盟国家、英国、美国和日本注册的药品数据。文章考虑了使用此类药物的局限性,包括其高昂的实用成本和不良反应的高风险。分析了先进疗法(包括儿科)提高临床疗效和经济可行性的潜力。
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