Browsing by Subject "Drug Evaluation"

Now showing 1 - 3 of 3
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    Access to patient-level data from GlaxoSmithKline clinical trials.
    (N Engl J Med, 2013-08-01) Nisen, Perry; Rockhold, Frank
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    Cost of innovation in the pharmaceutical industry.
    (J Health Econ, 1991-07) DiMasi, JA; Hansen, RW; Grabowski, HG; Lasagna, L
    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 drug development. The costs of abandoned NCEs were linked to the costs of NCEs that obtained marketing approval. For base case parameter values, the estimated out-of-pocket cost per approved NCE is $114 million (1987 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a 9% discount rate yielded an average cost estimate of $231 million (1987 dollars).
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    The price of innovation: new estimates of drug development costs.
    (J Health Econ, 2003-03) DiMasi, Joseph A; Hansen, Ronald W; Grabowski, Henry G
    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 compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per new drug is 403 million US dollars (2000 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 11% yields a total pre-approval cost estimate of 802 million US dollars (2000 dollars). When compared to the results of an earlier study with a similar methodology, total capitalized costs were shown to have increased at an annual rate of 7.4% above general price inflation.