转换医学研究与新药发现和研究开发

Translational research in discovery,research and development of new drugs

当前创新药物研究和发展的理论、方法和关键技术正在迅速兴起,它将有利于提高我国创新药物研究的实力和整体水平。为建立起我国药物研究的自主创新体系,使我国创新药物研究接近或达到发达国家的整体水平是我们面临的重大挑战。因此,应充分利用国际生命科学的最新发展,开展创新药物的基础和应用基础研究,建立高水平的创新药物研究体系,提高药物创新能力。在"关键路径研究"中,实施转换医学研究或转换研究不但影响医药企业的新产品研发过程,也会对研发机制产生深远的影响。特别是提出把握转换研究与新药研发三要素的关系,对提高研发效率十分重要。因而需要科学的支持系统用于评价路径,这些科学支持系统,包括技术标准、研究工具、注册政策和注册的科学标准等,以推进发明的实现。分析药物被淘汰的原因,可以认为转换研究链是关键,现有的动物疾病模型和安全性评价研究方法所获得资料运用到人、到疾病治疗,还有相当距离。其中以动力学研究为主线的ADME/E/T在转换研究链中起着极其重要的作用。

Current innovative drug research and development of the theory,methods,and key technology is the rapid emergence in China,which will be conducive to the research of innovative medicines to improve the strength and the overall level. For the es tablishment of China＇s independent innovation system, so we face major challenges in innovative drug research in China to reach close to the developed country＇s overall level. Therefore,the full use of the latest development of innovative medicines in the international life sciences,to carry out basic and applied basic research, the establishment of a high level of innovation in pharmaceutical research system, improve the drug innovation. In the critical path research, the implementation of the translational medicine or trans- lational research will not only affect the pharmaceutical enterprises of the new product development process, but also impact on the mechanism of innovative drug research. In particular to improve the efficiency of research and development, grasping the three elements is very importance in relationship between the translational research and new drug research and development. For scientific support systems of the critical path research, the scientific support system,including technical standards, research tools, registration policies and registration of scientific criteria will be useful to promote the realization of the invention. Analysing the causes of drug elimination,it can be considered that convertion of research chain is the key, the existing animal disease models and methods of safe- ty evaluation studies by the use of access to information to patents,to the treatment of disease,there is still a considerable distance. The translational research plays an extremely important role for pharmacokinetics as a main line in the ADME/E/T research chain.