论文部分内容阅读
创新药物研究和开发的理论、方法和关键技术随着生物技术的发展而发展,我国创新药物研究获得前所未有的机遇,也面临着重大挑战。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。转换医学为提高研究开发效率提供了机遇和挑战,在新药发现、研究开发、临床前和临床评价研究的各个阶段,应用转换研究模式,科学地利用获得的有用信息,把握转换研究与新药研发三要素,定能降低研发成本和缩短研究时间,提高研发效率和速度。笔者主要论述转换医学的发展、国际动态、我国创新药物研究所面临的机遇和挑战等方面的内容。
Theory, Methods and Key Technologies of Innovative Drug Research and Development With the development of biotechnology, innovative drug research in our country has gained unprecedented opportunities and challenges. In the study of Critical Paths, the implementation of translational medicine research or translational research will not only affect the pharmaceutical product development process, but also have a profound impact on the R & D mechanism. Translational medicine offers opportunities and challenges for improving the efficiency of research and development. In the phases of new drug discovery, research and development, preclinical and clinical evaluation studies, the transformational research model is applied to make scientific use of available information, Elements, will be able to reduce research and development costs and shorten the study time, improve research and development efficiency and speed. The author mainly discusses the development of translational medicine, international developments, the opportunities and challenges facing the Institute of Innovative Drugs in China.