Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association-Reference-Cited by-同舟云学术

Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

Published:2016-08-22 Issue:5 Volume:100 Page:558-564
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Gagne JJ¹,Han X²,Hennessy S²,Leonard CE²,Chrischilles EA³,Carnahan RM³,Wang SV¹,Fuller C⁴,Iyer A⁴,Katcoff H⁴,Woodworth TS⁴,Archdeacon P⁵,Meyer TE⁶,Schneeweiss S¹,Toh S⁴

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics; Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Boston Massachusetts USA

2. Center for Pharmacoepidemiology Research and Training; Center for Clinical Epidemiology and Biostatistics, and Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine; Philadelphia Pennsylvania USA

3. Department of Epidemiology; University of Iowa College of Public Health; Iowa City Iowa USA

4. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston Massachusetts USA

5. Office of Medical Policy; Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA

6. Division of Epidemiology; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.429/fullpdf

Reference22 articles.

1. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction;Platt;Pharmacoepidemiol. Drug Saf.,2012

2. The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program;Forrow;Pharmacoepidemiol. Drug Saf.,2012

3. Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative data: summary of findings and suggestions for future research;Carnahan;Pharmacoepidemiol. Drug Saf.,2012

4. Design considerations in an active medical product safety monitoring system;Gagne;Pharmacoepidemiol. Drug Saf.,2012

5. Design of a national distributed health data network;Maro;Ann. Intern. Med.,2009

Cited by 33 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. Application of the US Food and Drug Administration’s Sentinel Routine Querying Tools to the Taiwan Sentinel Data Model-formatted National Health Insurance Research Database;Journal of Food and Drug Analysis;2023-12-15

2. Comparative Risk of Angioedema With Sacubitril-Valsartan vs Renin-Angiotensin-Aldosterone Inhibitors;Journal of the American College of Cardiology;2023-01

3. Assessing medical product safety during pregnancy using parameterizable tools in the sentinel distributed database;Pharmacoepidemiology and Drug Safety;2022-12-14

4. A new analytic tool for assessing the impact of the US Food and Drug Administration regulatory actions;Pharmacoepidemiology and Drug Safety;2022-11-15

5. Evaluating Postmarket Vaccine Safety—Time to Consolidate This Mission at a Single Agency;JAMA Health Forum;2021-04-29