Market watch : Spending on postapproval drug safety

Health Affairs

Volumn 25, Issue 2, 2006, Pages 429-436

  Ridley, David B ^a   Kramer, Judith M ^b   Tilson, Hugh H ^c   Grabowski, Henry G ^d   Schulman, Kevin A ^a,e  

^a DUKE UNIVERSITY   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c The University of North Carolina at Chapel Hill   (United States)

^d DUKE UNIVERSITY   (United States)

^e University School of Medicine

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COST; DRUG APPROVAL; DRUG INDUSTRY; ECONOMICS; HUMAN; POSTMARKETING SURVEILLANCE; REGRESSION ANALYSIS; SAFETY; UNITED STATES;

COSTS AND COST ANALYSIS; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; REGRESSION ANALYSIS; SAFETY; UNITED STATES;

EID: 33645656709     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.25.2.429     Document Type: Review

References (34)

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4. An illustration of the flow and action in the U.S. postapproval safety surveillance system is available as an online supplement, at http://content.healthaffairs.org/cgi/content/full/25/2/429/DC1.
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7. See Trontell, "Expecting the Unexpected."
8. Gross and Strom, "Toward Improved Adverse Event Reporting";
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10. Centers for Education and Research on Therapeutics Risk Assessment Workshop, "Risk Assessment of Drugs, Biologics, and Therapeutic Devices: Present and Future Issues," Pharmacoepidemiology and Drug Safety 12, no. 8 (2003): 653-662;
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15. Top Companies," Contract Pharma 2005 http://www.contractpharma.com/ top_comp.php Ibid.
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21. Kennedy et al., "Spontaneous Reporting";
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23. See, for example, B.M. Psaty et al., "Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis," Journal of the American Medical Association 292, no. 21 (2004): 2622-2631;
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25. P.B. Fontanarosa, D. Rennie, and C.D. DeAngelis, "Postmarketing Surveillance - Lack of Vigilance, Lack of Trust," Journal of the American Medical Association 292, no. 21 (2004): 2647-2650;
26. and R.L. Woosley et al., "Mechanism of the Cardiotoxic Actions of Terfenadine," Journal of the American Medical Association 269, no. 12 (1993): 1532-1536.
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29. Deborah Gold, managing consultant, WCI, personal communication regarding the PVNet Benchmark published in January 2004, December 2004.
30. Okie, "Safety in Numbers";
31. K.I. Kaitin and C. Cairns, "The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992," Drug Information Journal 37 (2003): 357-371;
32. and H.G. Grabowski and Y.R. Wang, "The Quantity and Quality of Worldwide New Drug Introductions, 1982-2003," Health Affairs 25, no. 2 (2006): 452-460.
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