基于网络层次分析法的非专利药项目风险测评研究

On the Risk Evaluation Model of Generic Drug Project Based on an Analytic Network Process(ANP)

每年世界上有大量的专利药失去专利保护,为我国制药厂商进入国际非专利药市场带来了前所未有的机遇,但同时非专利药项目开发存在着巨大的风险。因此有必要对项目风险进行评测。非专利药项目开发风险评测模型是基于网络层次分析法的基本原理,结合非专利药新品开发的特点,通过构建非专利药项目的两级风险评价指标,并在对各指标间的相互关系进行了深入调研的基础上,绘制出了非专利药项目开发风险测评网络层次图。然后利用Super Decision(SD)软件对非专利药项目开发风险进行量化测评,评测结果对于厂商规避风险,选择合适的非专利药项目进行开发具有很好的指导作用。文章最后还应用该模型对非专利药项目开发风险进行了测评。

Every year, a large number of medicines lost their patent protection in the world, providing unprecedented opportunities for Chinese pharmaceutical manufactures to develop the generic drugs, but simultaneously there is a huge risk for the development of new generic drugs. In this paper, we have built the risk evaluation model for the development of new generic drug projects, which based on the principles of the analytic network process. We have studied the characteristics of the development of new generic drug projects and built two levels risk assessment indicators in this model. We developed the ANP risk assessment maps for new generic drug project by investigating the relationship of the indicators thoroughly. This model can easily quantify the risks facing the new generic drugs projects by using the software of super decisions（SD）.It provides a good guidance for generic medicine manufactures to avoid risk and choose the proper new generic drug projects. Finally, this model also was applied to the risk assessment in the development of new generic drugs.