国内外新药研发平台建设的初步比较  

Comparison of the new drug research and development platforms at home and abroad:a preliminary study

作　　者：张立国[1] 李鹏燕[1] 贾启燕[1] 赵瑾[1] 雷二庆[2] 毛军文[2] 

机构地区：[1]军事医学科学院毒物药物研究所科技处,北京100850 [2]军事医学科学院科技部,北京100850

出　　处：《国际药学研究杂志》2010年第3期170-173,共4页Journal of International Pharmaceutical Research

基　　金：国家“重大新药创制”科技重大专项--综合性新药研究开发技术大平台资助项目(2009ZX09301-002)

摘　　要：新药研发平台是整合新药研发技术体系及相关要素而构成的对研发新药具有基础支撑和综合集成载体作用的、开放完整并不断发展创新的有机系统。国际上政府层面的平台比较宏观综合,科研院所和大型制药公司层面的平台具有系统性、规模性,中小型制药公司层面的平台比较细致专业。我国新药研发平台的建设自"九五"以来经历了萌芽期、雏形期,现已在"重大新药创制"科技重大专项的支持下步入全面建设期,从单一技术性的研发中心发展到包含完整研发链条的综合性技术平台。本文通过比较分析国内外平台建设情况,对今后我国新药研发平台的建设和管理提出了建议和展望。The new drug research and development（R D） platforms are comprehensive,open and continuously developing organic systems which integrate such elements as technologies and standards related to the R D of innovative drugs and serve as pillars and integration media. These platforms are macroscopic and integrated at the governmental level,large and systematic in big pharmaceutical enterprises and research institutes,and detailed and professional in medium and small enterprises. The construction of new drug R D platforms in China experienced germination and rudiment stages during ＂9th Five-year＂ period,and has now entered the full-fledged developing stage with the support of Scientific and Technological Major Special Project-＂Key New Drugs Creation and Manufacturing＂ ,and has evolved from single technological R D centers to integrated technology platforms with complete pipelines. By comparing the development of domestic and international new drug R D platforms,this paper puts forward some suggestions on how to develop and manage the Chinese platform and examines its future prospects.

关 键 词：新药研发 平台建设 技术平台 

分 类 号：R9-3[医药卫生—药学] R28