Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs-Reference-Cited by-同舟云学术

Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs

Published:2013-08-07 Issue:10 Volume:22 Page:1036-1045
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Toh Sengwee¹,Avorn Jerry²,D'Agostino Ralph B.³,Gurwitz Jerry H.⁴⁵,Psaty Bruce M.⁶⁷,Rothman Kenneth J.²⁸⁹,Saag Kenneth G.¹⁰,Sturkenboom Miriam C. J. M.¹¹,Vandenbroucke Jan P.¹²,Winterstein Almut G.¹³¹⁴,Strom Brian L.¹⁵

Affiliation:

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

2. Division of Pharmacoepidemiology and Pharmacoeconomics; Brigham and Women's Hospital and Harvard Medical School; Boston MA USA

3. Department of Mathematics and Statistics; Boston University; Boston MA USA

4. Division of Geriatric Medicine; University of Massachusetts Medical School; Worcester MA USA

5. Meyers Primary Care Institute; Worcester MA USA

6. Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services; University of Washington; Seattle WA USA

7. Group Health Research Institute; Seattle WA USA

8. RTI Health Solutions; RTI International; Research Triangle Park NC USA

9. Department of Epidemiology; Boston University School of Public Health; Boston MA USA

10. Division of Clinical Immunology and Rheumatology; The University of Alabama at Birmingham; Birmingham AL USA

11. Departments of Epidemiology and Medical Informatics; Erasmus University Medical Center; Rotterdam The Netherlands

12. Department of Clinical Epidemiology; Leiden University Medical School; Leiden The Netherlands

13. Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; University of Florida; Gainesville FL USA

14. Department of Epidemiology, College of Public Health and Health Professions and College of Medicine; University of Florida; Gainesville FL USA

15. Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine; University of Pennsylvania; Philadelphia PA USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3478/fullpdf

Reference30 articles.

1. Food and Drug Administration Amendments Act (FDAAA) of 2007 2007 http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm

2. Developing the Sentinel System-a national resource for evidence development;Behrman;N Engl J Med,2011

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

4. The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety;Robb;Pharmacoepidemiol Drug Saf,2012

5. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise;Nguyen;Pharmacoepidemiol Drug Saf,2012

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