规划治疗慢性丙型肝炎药物的预授权临床试验项目

A. Gubenko, N. Eremenko
{"title":"规划治疗慢性丙型肝炎药物的预授权临床试验项目","authors":"A. Gubenko, N. Eremenko","doi":"10.30895/1991-2919-2019-9-1-6-13","DOIUrl":null,"url":null,"abstract":"In 2016 the WHO Assembly defined a global strategy to combat viral hepatitis viruses, which seeks to eliminate these infections by 2030. The most important goals of this programme, adopted by 194 countries, are to reduce the incidence of viral hepatitis by 90 % and mortality rates – by 65 % as compared to the levels observed in 2016. Therefore, there is an obvious need for development of medicines for the treatment of chronic hepatitis C. The aim of the present paper was to determine basic approaches to planning pre-authorisation clinical trials for the main groups of medicines for the treatment of chronic hepatitis C. The paper summarises the current trends in the treatment of chronic hepatitis C; it lists medicines with direct antiviral effect that are currently registered in the Russian Federation, as well as interferon-free and interferon-containing regimens for the treatment of this disease. The authors examined the current requirements in force in the Russian Federation, namely: the Federal Law No. 61-FZ «On circulation of medicines» dated April 12, 2010, the Guideline on Evaluation of Medicinal Products, the Clinical Recommendations for Diagnosis and Treatment of Adult Patients with Hepatitis C, as well as recommendations of the European Medicines Agency and the Food and Drug Administration in order to analyse the planning of programmes of pre-authorisation clinical trials of interferon alfa products and direct antivirals. ","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Planning a Programme of Pre-authorisation Clinical Trials of Medicines for the Treatment of Chronic Hepatitis C\",\"authors\":\"A. Gubenko, N. Eremenko\",\"doi\":\"10.30895/1991-2919-2019-9-1-6-13\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In 2016 the WHO Assembly defined a global strategy to combat viral hepatitis viruses, which seeks to eliminate these infections by 2030. The most important goals of this programme, adopted by 194 countries, are to reduce the incidence of viral hepatitis by 90 % and mortality rates – by 65 % as compared to the levels observed in 2016. Therefore, there is an obvious need for development of medicines for the treatment of chronic hepatitis C. The aim of the present paper was to determine basic approaches to planning pre-authorisation clinical trials for the main groups of medicines for the treatment of chronic hepatitis C. The paper summarises the current trends in the treatment of chronic hepatitis C; it lists medicines with direct antiviral effect that are currently registered in the Russian Federation, as well as interferon-free and interferon-containing regimens for the treatment of this disease. The authors examined the current requirements in force in the Russian Federation, namely: the Federal Law No. 61-FZ «On circulation of medicines» dated April 12, 2010, the Guideline on Evaluation of Medicinal Products, the Clinical Recommendations for Diagnosis and Treatment of Adult Patients with Hepatitis C, as well as recommendations of the European Medicines Agency and the Food and Drug Administration in order to analyse the planning of programmes of pre-authorisation clinical trials of interferon alfa products and direct antivirals. \",\"PeriodicalId\":22286,\"journal\":{\"name\":\"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-03-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.30895/1991-2919-2019-9-1-6-13\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.30895/1991-2919-2019-9-1-6-13","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1

摘要

2016年,世卫组织大会确定了一项抗击病毒性肝炎病毒的全球战略,力求到2030年消除这些感染。194个国家通过的这一规划的最重要目标是,与2016年观察到的水平相比,将病毒性肝炎发病率降低90%,将死亡率降低65%。因此,开发治疗慢性丙型肝炎的药物显然是有必要的。本文的目的是确定规划用于治疗慢性丙型肝炎的主要药物组的预授权临床试验的基本方法。它列出了目前在俄罗斯联邦注册的具有直接抗病毒作用的药物,以及治疗这种疾病的无干扰素和含干扰素方案。作者审查了俄罗斯联邦现行的规定,即:2010年4月12日第61-FZ号“药品流通”联邦法,药品评价指南,成年丙型肝炎患者诊断和治疗临床建议,以及欧洲药品管理局和食品药品管理局的建议,以分析干扰素产品和直接抗病毒药物的预授权临床试验方案的规划。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Planning a Programme of Pre-authorisation Clinical Trials of Medicines for the Treatment of Chronic Hepatitis C
In 2016 the WHO Assembly defined a global strategy to combat viral hepatitis viruses, which seeks to eliminate these infections by 2030. The most important goals of this programme, adopted by 194 countries, are to reduce the incidence of viral hepatitis by 90 % and mortality rates – by 65 % as compared to the levels observed in 2016. Therefore, there is an obvious need for development of medicines for the treatment of chronic hepatitis C. The aim of the present paper was to determine basic approaches to planning pre-authorisation clinical trials for the main groups of medicines for the treatment of chronic hepatitis C. The paper summarises the current trends in the treatment of chronic hepatitis C; it lists medicines with direct antiviral effect that are currently registered in the Russian Federation, as well as interferon-free and interferon-containing regimens for the treatment of this disease. The authors examined the current requirements in force in the Russian Federation, namely: the Federal Law No. 61-FZ «On circulation of medicines» dated April 12, 2010, the Guideline on Evaluation of Medicinal Products, the Clinical Recommendations for Diagnosis and Treatment of Adult Patients with Hepatitis C, as well as recommendations of the European Medicines Agency and the Food and Drug Administration in order to analyse the planning of programmes of pre-authorisation clinical trials of interferon alfa products and direct antivirals. 
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Analysis of the Medicinal Products for Human Use Authorised in the Russian Federation Diffusion-Ordered NMR Spectroscopy Application for Analysis of Polysaccharides Determination of Heavy Metals, Arsenic, and Aluminum Content in Pumpkin Seed Herbal Substance and Native Products, by Inductively Coupled Plasma Mass Spectrometry The Use of Spectroscopic Methods for Structural Elucidation of Individual Secondary Metabolites Isolated from the Aerial Parts of Corydalis bracteata NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1