试析新药研发过程中的转化研究链

发布时间：2018-05-16 13:43

本文选题：新药 + 生物标志物　；参考：《中国药房》2015年04期

【摘要】：目的:为构建具有我国特色的新药转化研究链保证体系提供参考。方法:分析当前转化研究链对新药研发过程凸显的制约作用,评述新药转化研究中的关键课题,探讨新药转化研究体系的构建与发展。结果:转化研究贯穿新药研发过程始终,生物标志物、动物实验模型、遗传药理学、网络药理学等的研究与应用是新药转化链中的关键课题。建议通过各层面综合配套的改革创新措施,对新药转化研究协作、转化型人才培养、资本风险投入、国际合作交流机制等加以规范化推进,建立健全以患者为中心的新药转化研究公共平台与切合我国实际情况的政策法规体系,以有效破解新药研发风险及其效率低下的困境,加快我国新药发展步伐。结论:践行转化医学理念,科学的顶层设计和统筹规划不可或缺;必须充分利用我国独特优势,着力优化新药转化研究工作环境,从而保障新药转化研究链的实效运行。
[Abstract]:Objective: to provide a reference for the establishment of a new drug transformation research chain guarantee system with Chinese characteristics. Methods: the restriction effect of the current transformation research chain on the process of new drug development was analyzed, the key issues in the research of new drug transformation were reviewed, and the construction and development of the new drug transformation research system were discussed. Results: the research and application of biomarkers, animal experimental models, genetic pharmacology and network pharmacology are the key issues in the new drug transformation chain. It is suggested that through comprehensive reform and innovation measures at various levels, we should standardize the cooperation in the research of new drug transformation, the cultivation of transformational talents, the investment of capital risks, the mechanism of international cooperation and exchange, etc. To establish and perfect the public platform of new drug transformation research centered on patients and the system of policies and regulations in accordance with the actual situation of our country, in order to effectively solve the plight of risk and inefficiency of new drug research and development, and accelerate the pace of new drug development in China. Conclusion: scientific top-level design and overall planning are indispensable in carrying out the concept of transformational medicine, and we must make full use of our unique advantages and make great efforts to optimize the working environment of new drug transformation research, so as to ensure the effective operation of the new drug transformation research chain.
【作者单位】：安徽理工大学化学工程学院制药工程系;
【基金】：国家自然科学基金青年基金资助项目(No.21102003)
【分类号】：R95

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