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.

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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

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