DiMasi J A, Hansen R W, Grabowski H G, Lasagna L
Center for the Study of Drug Development, Tufts University, Boston, MA 02111.
J Health Econ. 1991 Jul;10(2):107-42. doi: 10.1016/0167-6296(91)90001-4.
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).
从对12家美国制药公司的调查中获取了93个随机选择的新化学实体（NCE）的研发成本。这些数据用于估算新药研发的税前平均成本。放弃的NCE的成本与获得上市批准的NCE的成本相关联。对于基础案例参数值，每个获批NCE的估计自付成本为1.14亿美元（1987年美元）。以9%的贴现率将自付成本资本化至上市批准时点，得出的平均成本估计为2.31亿美元（1987年美元）。
