Now showing items 1-20 of 20

    • 3Rs for innovating novel antibiotics: sharing resources, risks, and rewards. 

      So, Anthony D; Ruiz-Esparza, Quentin; Gupta, Neha; Cars, Otto (BMJ, 2012-04-03)
    • Access to patient-level data from GlaxoSmithKline clinical trials. 

      Nisen, Perry; Rockhold, Frank (N Engl J Med, 2013-08-01)
    • An interview with Professor Robert J. Lefkowitz, M.D. Interview by Vicki Glaser. 

      Lefkowitz, Robert J (Assay Drug Dev Technol, 2003-04)
      Robert J. Lefkowitz, M.D., is James B. Duke Professor of Medicine and Professor of Biochemistry at the Duke University Medical Center. He has been an Investigator of the Howard Hughes Medical Institute since 1976. Dr. Lefkowitz ...
    • Compliance with results reporting at 

      Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M (N Engl J Med, 2015-03-12)
      BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to We characterized the proportion of applicable clinical trials ...
    • Cost of innovation in the pharmaceutical industry. 

      DiMasi, JA; Hansen, RW; Grabowski, HG; Lasagna, L (J Health Econ, 1991-07)
      The research and development costs of 93 randomly selected new chemical entities (NCEs) were obtained from a survey of 12 U.S.-owned pharmaceutical firms. These data were used to estimate the pre-tax average cost of new ...
    • Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. 

      Rockhold, FW; Enas, GG (Stat Med, 1993-03)
      The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring ...
    • Developing drugs for developing countries. 

      Ridley, David; Moe, Jeffrey (Health Aff (Millwood), 2006-03)
      Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments ...
    • Economic return of clinical trials performed under the pediatric exclusivity program. 

      Li, Jennifer; Eisenstein, Eric; Reid, Elizabeth; Mangum, Barry; Schulman, Kevin; Goldsmith, John; Murphy, M Dianne; ... (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 ...
    • 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 ...
    • Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention. 

      Moe, Jeffrey L (Cancer Prev Res (Phila), 2008-07)
      Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, ...
    • Pediatric Antibacterial and Antifungal Trials From 2007 to 2017. 

      Thaden, Joshua T; Chiswell, Karen; Jaffe, Ian; Bergin, Stephen P; Yang, William E; Romaine, Andrew; Roberts, Jamie; ... (12 authors) (Pediatrics, 2018-09)
      BACKGROUND AND OBJECTIVES:The impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial or antifungal drug trials is unknown. Our objective was to ...
    • Returns to R&D on new drug introductions in the 1980s. 

      Grabowski, HG; Vernon, JM (J Health Econ, 1994-12)
      This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes ...
    • Should the patent system for new medicines be abolished? 

      DiMasi, JA; Grabowski, HG (Clin Pharmacol Ther, 2007-11)
    • Spending on postapproval drug safety. 

      Ridley, David; Kramer, Judith; Tilson, Hugh; Schulman, Kevin (Health Aff (Millwood), 2006-03)
      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 ...
    • Strategic use of statistical thinking in drug development. 

      Rockhold, FW (Stat Med, 2000-12-15)
      The role of the statistician and statistical thinking in the pharmaceutical industry has evolved greatly in the last four or five decades. Regulatory developments and the changing face of the science of drug development ...
    • The cost of drug development. 

      DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W (N Engl J Med, 2015-05-14)
    • The distribution of sales revenues from pharmaceutical innovation. 

      Grabowski, HG; Vernon, J (Pharmacoeconomics, 2000)
      OBJECTIVE: This report updates our earlier work on the returns to pharmaceutical research and development (R&D) in the US (1980 to 1984), which showed that the returns distributions are highly skewed. It evaluates a more ...
    • The price of innovation: new estimates of drug development costs. 

      DiMasi, Joseph A; Hansen, Ronald W; Grabowski, Henry G (J Health Econ, 2003-03)
      The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of ...
    • The quantity and quality of worldwide new drug introductions, 1982-2003. 

      Grabowski, Henry G; Wang, Y Richard (Health Aff (Millwood), 2006-03)
      We examined trends in the introduction of new chemical entities (NCEs) worldwide from 1982 through 2003. Although annual introductions of NCEs decreased over time, introductions of high-quality NCEs (that is, global and ...
    • The roles of patents and research and development incentives in biopharmaceutical innovation. 

      Grabowski, Henry G; DiMasi, Joseph A; Long, Genia (Health Aff (Millwood), 2015-02)
      Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms ...