FEATURES OF THE ORGANIZATION OF CLINICAL TRIALS OF NARCOTIC DRUGS IN RUSSIA

G. Gildeeva, E. A. Ezhova, D. V. Butuzova, N. L. Mishchenko, V. Yurkov, A. V. Teteneva, T. S. Ageeva
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Abstract

The problem of ensuring the necessary level of availability of narcotic drugs (NLP) in the Russian Federation, especially in the framework of palliative medical care for oncological patients is the area of special and constant attention of the Government and civil society. Recently, a number of necessary changes of the legislation aimed at simplifying the procedures for prescribing and issuing NLP have been introduced, and the possibility of optimizing the rules for their storage and accounting as well as improving the methods for calculating the needs for such drugs are being actively discussed.As part of the import substitution program in Russia, the new dosage forms for NLP are under development. Such process is accompanied by clinical studies with a number of features that take into account the specific chemical composition of finished products.
俄罗斯麻醉药品临床试验的组织特点
确保俄罗斯联邦麻醉药品供应的必要水平的问题,特别是在为肿瘤患者提供缓和医疗护理的框架内,是政府和民间社会特别和持续关注的领域。最近,对立法进行了一些必要的修改,目的是简化NLP的处方和发放程序,目前正在积极讨论是否有可能优化NLP的储存和核算规则以及改进计算这类药物需求的方法。作为俄罗斯进口替代计划的一部分,NLP的新剂型正在开发中。这一过程伴随着临床研究,其中考虑到成品的特定化学成分的许多特征。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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