首页> 美国卫生研究院文献>Health Research Policy and Systems >Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews

【2h】

Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews

机译：为何欧美药品监管机构对抗流感药物的看法不一：监管审查方法和深度产品审查的重要性

代理获取

本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。

页面导航

摘要
著录项
相似文献
相关主题

摘要

BackgroundRelenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs.

机译：背景勒伦扎代表第一种神经氨酸酶抑制剂（NI），这是一类药物，其中还包括达菲。尽管被认为是流感的突破性治疗方法，但NI的疗效仍然存在很大争议。尚未解决的关键问题是，为什么美国食品药品管理局（FDA）批准了比欧洲监管机构对这两种药物更为谨慎的功效声明。

著录项

期刊名称 Health Research Policy and Systems
作者
Shai Mulinari; Courtney Davis;
展开▼
作者单位

展开▼
年(卷),期 2017(15),-1
年度 2017
页码 93
总页数 14
原文格式 PDF
正文语种
中图分类
关键词
Neuraminidase inhibitor Influenza Meta-analysis United States Food and Drug Administration European Medicines Agency;

机译：神经氨酸酶抑制剂;流感;荟萃分析;美国食品药品监督管理局;欧洲药品管理局;

相似文献

外文文献
中文文献
专利

1. Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews [J] . Shai Mulinari, Courtney Davis Health Research Policy and Systems . 2017,第1期

机译：为什么欧洲和美国药物监管机构不与一种关于抗流感药物的声音发言：监管审查方法和“深度”产品评论的重要性
2. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA [J] . Robert W. Makuch, Ruizhi Shi Drug information journal . 2014,第3期

机译：欧洲与美国的药品批准比较：EMA和FDA审查的药品之间的差异分析
3. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA [J] . Makuch Robert W., Shi Ruizhi Therapeutic innovation & regulatory science. . 2014,第3期

机译：欧洲与美国的药品批准比较：EMA和FDA审查的药品之间的差异分析
4. Drug Recommendation System based on Sentiment Analysis of Drug Reviews using Machine Learning [C] . Satvik Garg International Conference on Cloud Computing, Data Science and Engineering . 2021

机译：基于机器学习的药物评价情绪分析药品推荐系统
5. A Review of Bioequivalence Assessment Techniques for Topical Drug Products [D] . Patel, Tulsi Rashesh. 2020

机译：局部药品的生物等效评估技术述评
6. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants between the USA and Europe: a comparison review of paired regulatory documents [O] . Victoria R Cornelius, Kun Liu, Janet Peacock, 2016

机译：美国和欧洲之间抗抑郁药和抗惊厥药产品信息中列出的药物不良反应变化：配对法规文件的比较审查
7. Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs:Regulatory review methodologies and the importance of 'deep' product reviews [O] . Mulinari Shai, Davis Courtney 2017

机译：为何欧美药物监管机构对抗流感药物的看法不一：监管审查方法和``深度''产品审查的重要性

Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews

摘要

著录项

相似文献

相关主题

期刊订阅