Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency
Author:
Affiliation:
1. Office of Medical Informatics and Epidemiology; Pharmaceuticals and Medical Devices Agency; Tokyo Japan
Publisher
Wiley
Subject
Pharmacology (medical),Epidemiology
Reference14 articles.
1. Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay?;Yamada;Ann Pharmacother,2010
2. Evaluation of FDA safety-related drug label changes in 2010;Lester;Pharmacoepidemiol Drug Saf,2013
3. A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009;Mol;Drug Saf,2010
4. PMDA Annual Report 2014. PMDA, Tokyo 2015 http://www.pmda.go.jp/files/000206931.pdf
5. PMDA Annual Report 2012. PMDA, Tokyo 2013 https://www.pmda.go.jp/files/000156512.pdf
Cited by 16 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan;Frontiers in Medicine;2023-02-23
2. Characteristics of drug safety alerts issued by the Spanish Medicines Agency;Frontiers in Pharmacology;2023-01-30
3. Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019;Therapeutic Innovation & Regulatory Science;2022-08-13
4. Association between Post-marketing Safety-related Regulatory Actions and Characteristics of New Drugs Approved in Japan between 2005 and 2016;YAKUGAKU ZASSHI;2022-07-01
5. Drug Safety Assessment and the MID-NET® (Japanese Medical Information Database Network);SpringerBriefs for Data Scientists and Innovators;2022
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3