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The role of databases in drug postmarketing surveillance
Open accessAbstract
This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we have used for assembling these adverse event reports into a case series and analysing them, as well as techniques for employing drug use databases to construct reporting rates in the evaluation of drug safety issues. Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision‐making. Published in 2001 by John Wiley & Sons, Ltd.
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Cited by
Data Mining of the Public Version of the FDA Adverse Event Reporting System
Sakaeda, T., Tamon, A., Kadoyama, K., & Okuno, Y. (2013) · International Journal of Medical Sciences · doi:10.7150/ijms.6048 · Cited by 1,048
Quantitative signal detection using spontaneous ADR reporting
Bate, A., & Evans, S. J. W. (2009) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.1742 · Cited by 912
Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005
Moore, T. J. (2007) · Archives of Internal Medicine · doi:10.1001/archinte.167.16.1752 · Cited by 462
Statin safety: an appraisal from the adverse event reporting system
Davidson, M. H., Clark, J. A., Glass, L. M., & Kanumalla, A. (2006) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2005.12.008 · Cited by 113
Metadata
- Authors
- Rodriguez, E. M., Staffa, J. A., & Graham, D. J.
- Venue
- Pharmacoepidemiology and Drug Safety
- Publisher
- Wiley
- Published
- 2001-08
- Volume
- 10
- Issue
- 5
- Pages
- 407-410
- ISSN
- 1053-8569 (ISSN-L)
- 1099-1557
- OpenAlex
- W2068871297
- Cited by
- 165
- References
- 0
- FWCI
- 2.82
- Type
- journal article
- Language
- en
- Open access
- green
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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