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Spending on postapproval drug safety.

dc.contributor.author Grabowski, Henry G
dc.contributor.author Kramer, JM
dc.contributor.author Ridley, David Blaine
dc.contributor.author Schulman, Kevin Alan
dc.contributor.author Tilson, HH
dc.coverage.spatial United States
dc.date.accessioned 2013-03-21T13:28:23Z
dc.date.issued 2006-03
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/16522583
dc.identifier 25/2/429
dc.identifier.uri https://hdl.handle.net/10161/6397
dc.description.abstract Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was 56 million dollars (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that total spending on postapproval safety by the top twenty drug manufacturers was 800 million dollars in 2003. We also examined, using regression analysis, the relationship between the number of safety personnel and the number of initial adverse-event reports. This study offers information for the debate on proposed changes to safety surveillance.
dc.language eng
dc.relation.ispartof Health Aff (Millwood)
dc.relation.isversionof 10.1377/hlthaff.25.2.429
dc.subject Costs and Cost Analysis
dc.subject Drug Approval
dc.subject Drug Industry
dc.subject Humans
dc.subject Product Surveillance, Postmarketing
dc.subject Regression Analysis
dc.subject Safety
dc.subject United States
dc.title Spending on postapproval drug safety.
dc.type Journal article
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/16522583
pubs.begin-page 429
pubs.end-page 436
pubs.issue 2
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Duke Science & Society
pubs.organisational-group Economics
pubs.organisational-group Fuqua School of Business
pubs.organisational-group Global Health Institute
pubs.organisational-group Initiatives
pubs.organisational-group Institutes and Centers
pubs.organisational-group Institutes and Provost's Academic Units
pubs.organisational-group Medicine
pubs.organisational-group Medicine, General Internal Medicine
pubs.organisational-group School of Medicine
pubs.organisational-group Trinity College of Arts & Sciences
pubs.organisational-group University Institutes and Centers
pubs.publication-status Published
pubs.volume 25
dc.identifier.eissn 1544-5208


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