Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications
Author:
Publisher
Public Library of Science (PLoS)
Subject
Multidisciplinary
Reference22 articles.
1. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000–2012;LV Sacks;JAMA,2014
2. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012;NS Downing;JAMA,2014
3. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study;E Maund;BMJ,2014
4. Challenges in coding adverse events in clinical trials: a systematic review;JB Schroll;PLoS One,2012
5. MedDRA: an overview of the Medical Dictionary for Regulatory Activities;P Mozzicato;Pharmaceut Med,2009
Cited by 11 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. Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database;Expert Opinion on Drug Safety;2023-01-27
2. MedDRA Labeling Groupings to Improve Safety Communication in Product Labels;Therapeutic Innovation & Regulatory Science;2022-08-08
3. Prediction of Adverse Drug Reaction Linked to Protein Targets Using Network-Based Information and Machine Learning;Frontiers in Bioinformatics;2022-07-14
4. Mining drug–target and drug–adverse drug reaction databases to identify target–adverse drug reaction relationships;Database;2021-10-01
5. Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study;Pharmaceuticals;2020-10-21
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