Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

Alexandre Vivot; Jean-David Zeitoun; Joseph S Ross; Ignacio Atal; Philippe Ravaud; Gabriel Baron; Nicholas S Downing

首页> 外文期刊>BMJ Open >Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

【24h】

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

机译：2005年至2010年间由FDA和EMA批准的新药上市后研究：一项横断面研究

获取原文

掌桥外文数据库（机构版） >>

开具论文收录证明 >>

页面导航

摘要
著录项
相似文献
相关主题

摘要

Abstract Objectives To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency. Design and setting Cross-sectional analysis of postmarketing studies registered in Clini

机译：摘要目的表征美国食品药品监督管理局和欧洲药品管理局新批准的药品的上市后研究。设计和设置在Clini中注册的售后研究的横断面分析

著录项

来源
《BMJ Open》 |2017年第12期|共页
作者
Alexandre Vivot; Jean-David Zeitoun; Joseph S Ross; Ignacio Atal; Philippe Ravaud; Gabriel Baron; Nicholas S Downing;
展开▼
作者单位

展开▼
收录信息
原文格式 PDF
正文语种
中图分类临床医学;
关键词
入库时间 2022-08-18 17:41:34

相似文献

外文文献
中文文献
专利

1. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis [J] . Zeitoun Jean-David, Ross Joseph S., Atal Ignacio, Clinical Pharmacology and Therapeutics . 2018,第5期

机译：与2005年至2010年FDA和EMA批准的新型药物批准指示的批准适应性相关的因素：多变量分析
2. Post‐marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross‐sectional study [J] . Zeitoun Jean‐David, Baron Gabriel, Vivot Alexandre, International Journal of Cancer =: Journal International du Cancer . 2018,第2期

机译：营销后的研究及其2005年至2010年间FDA和EMA批准的新型抗癌代理商的结果：横断面研究
3. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study [J] . Zeitoun Jean-David, Lefevre Jeremie H., Downing Nicholas S., Pharmacoepidemiology and drug safety . 2016,第6期

机译：EMA在2001年至2010年间批准的新药上市后安全问题的监管预期：一项横断面研究
4. Using Machine Learning to Predict the Binding Dissociation of FDA Approved Drugs for Affinity- Based Drug Delivery Applications [C] . Edgardo Rivera-Delgado, Alison Xin, Horst A. von Recum Society for Biomaterials annual meeting and exposition . 2019

机译：使用机器学习预测基于亲和力的药物递送应用的FDA批准药物的结合解离
5. Evidence Supporting FDA Approval and CMS National Coverage Determinations for Novel Medical Products, 2005 through 2016: A Cross-Sectional Study [D] . Roginiel, Aliya C. 2019

机译：证据支持FDA批准和CMS全国新型医疗产品的覆盖范围，2005年至2016年：横断面研究
6. Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study [O] . Jean-David Zeitoun, Joseph S Ross, Ignacio Atal, 2017

机译：2005年至2010年间由FDA和EMA批准的新药上市后研究：一项横断面研究
7. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study [O] . Zeitoun, Jean-David, Lefèvre, Jérémie H., Downing, Nicholas, 2015

机译：2001年至2010年间EMA批准的新药监管审查时间和上市后安全事件：一项横断面研究
8. Guidance for FDA Staff and Industry: Marketed Unapproved Drugs. Compliance Policy Guide. Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (September 19, 2011) [R] . 2011

机译：FDa工作人员和行业指南：未经批准的未经批准的药物。合规政策指南。秒。 440.100未经批准的NDa或aNDa上市的新药（2011年9月19日）

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

摘要

著录项

相似文献

相关主题

期刊订阅