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当今世界全球化深入各行各业,新药研发在全球化浪潮下发生了翻天覆地的变化。面对FDA批准的新药减少以及研发成本增加,合同研究组织(Contract Research Organization,CRO)应运而生,通过组建研发团队对研发活动进行分解,降低复杂性整合优势,缩短新药的研发周期和经费,同时在CRO的基础上,小巧而高效的虚拟实验室随之兴起,挑战传统的大型制药公司,在新药研发领域,发挥着越来越重要的作用。因此本文通过对新药研发的现状分析以及对组建CRO和虚拟实验室优势的探讨,总结出我国在未来新药研发道路上的发展模式,希望为我国新药研发事业赶超世界水平,共计献策。
In today’s world of globalization, all walks of life are deeply involved in globalization, and the development of new drugs has undergone tremendous changes under the tide of globalization. Faced with the reduction of new drugs approved by the FDA and the increase of R & D costs, the Contract Research Organization (CRO) came into being to break up R & D activities by setting up research and development teams to reduce the complexity of integration and shorten the research and development cycle and funding of new drugs. At the same time on the basis of the CRO, a small and efficient virtual laboratory has emerged to challenge the traditional large-scale pharmaceutical companies and play an increasingly important role in the research and development of new drugs. Therefore, through the analysis of the status quo of new drug research and development and the advantages of establishing CRO and virtual laboratory, this article summarizes the development model of our country in the future R & D of new drugs, hoping to catch up with the world level for new drug research and development.