Linked Life Data

11802586

Source:http://linkedlifedata.com/resource/pubmed/id/11802586

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2002-1-22
pubmed:abstractText
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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1053-8569
pubmed:author
pubmed:issnType
Print
pubmed:volume
10
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
407-10
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:articleTitle
The role of databases in drug postmarketing surveillance.
pubmed:affiliation
Division of Drug Risk Evaluation II, Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, HFD-440, Rockville, MD 20857, USA. rodrigueze@cder.fda.gov
pubmed:publicationType
Journal Article, Case Reports