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    Economics of new oncology drug development. 

    DiMasi, Joseph A; Grabowski, Henry G (J Clin Oncol, 2007-01-10)
    PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company ...
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    Entry and competition in generic biologics 

    Grabowski, Henry G; Ridley, David Blaine; Schulman, Kevin Alan (Managerial and Decision Economics, 2007-06-01)
    Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In ...
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    Should the patent system for new medicines be abolished? 

    DiMasi, Joseph A; Grabowski, Henry G (Clin Pharmacol Ther, 2007-11)
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    Generic competition and market exclusivity periods in pharmaceuticals 

    Grabowski, Henry G; Kyle, Margaret (Managerial and Decision Economics, 2007-06-01)
    In this paper we examine generic competition and market exclusivity periods for pharmaceuticals experiencing their initial generic entry between 1995 and 2005. We find that generic competition has increased over several ...
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    The cost of biopharmaceutical R&D: Is biotech different? 

    DiMasi, Joseph A; Grabowski, Henry G (Managerial and Decision Economics, 2007-06-01)
    The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been published on the costs of developing ...
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    Economic return of clinical trials performed under the pediatric exclusivity program. 

    Benjamin, Daniel Kelly; Califf, Robert M; Eisenstein, EL; Goldsmith, JV; Grabowski, Henry G; Li, JS; Mangum, B; ... (10 authors) (JAMA, 2007-02-07)
    CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
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    Competition between Generic and Branded Drugs 

    Grabowski, Henry G (Pharmaceutical innovation: incentives, competition, and cost-benefit analysis in international perspective, 2007-04-30)
    The pharmaceutical industry worldwide is a rapidly burgeoning industry contributing to growth of gross domestic product and employment. Technological change in this field has been very rapid, with many new products being ...
     

     

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    Author
    Grabowski, Henry G (7)
    DiMasi, Joseph A (3)Schulman, Kevin Alan (2)Benjamin, Daniel Kelly (1)Califf, Robert M (1)Eisenstein, EL (1)Goldsmith, JV (1)Kyle, Margaret (1)Li, JS (1)Mangum, B (1)... View MoreDate Issued
    2007 (7)
    TypeJournal article (6)Book section (1)SubjectDrug Costs (3)Drug Industry (3)Drug Approval (2)Humans (2)United States (2)Antineoplastic Agents (1)Biomedical Research (1)Business & Economics (1)Clinical Trials as Topic (1)Cohort Studies (1)... View MoreAffiliation of Duke Author(s)Duke (7)Economics (7)
    Trinity College of Arts & Sciences (7)
    Clinical Science Departments (2)Duke Cancer Institute (2)Duke Clinical Research Institute (2)Duke Science & Society (2)Global Health Institute (2)Initiatives (2)Institutes and Centers (2)... View More