三维导向转换模式在新药研究开发中的应用  

Application of translational three-dimension model to research and development of new drug

作　　者：杨明[1,2] 伍振峰[1,2] 岳鹏飞[1] 胡鹏翼[1] 魏韶锋[1] 邓中银[1] 郑琴[1] 

机构地区：[1]江西中医学院现代中药制剂教育部重点实验室,江西南昌330004 [2]成都中医药大学,四川成都610075

出　　处：《中草药》2012年第3期417-421,共5页Chinese Traditional and Herbal Drugs

基　　金："十一五"重大新药创制项目"中药新型给药系统技术平台"(2009ZX09310-005);公益性行业科研专项(200807038);江西省自然科学基金项目(2010GQY0179);江西省教育厅科技项目(GJJ11549);江西省卫生厅项目(2011A139)

摘　　要：近年来新药研究开发风险和难度逐渐增大,研发的成功率不增反降。我国新药研发模式存在的问题和不足正逐渐显露出来,在现行新药审批制度正趋于公正、科学、合理的大背景下,研发体系面临着巨大挑战的同时也迎来了新的发展机遇。现就新药研发过程中涉及的临床、市场及生产过程进行探讨,提出构建三维导向下的新药研发模式的重要性,并强调临床试验设计、市场需求以及生产过程的适应性问题是影响新药研发的关键因素,通过对问题的分析和讨论,以期提高新药研发的效率和成功率,为相关新药研究提供参考。In recent years,risks and difficulties in the drug research and development（RD） have been gradually increasing,while success rate has been cut down.Problems and defects of the pattern in new drug RD are emerging.Under the overall background,the current new drug approval system tends to be unprejudiced,scientific,and rational,research systems are facing huge challenge while meeting a new developing opportunity.This paper has probed into clinic,market,and the procedure of production referring the process of RD,hence putting forward the significance of the pattern under the three-dimensional guide,emphasizing that design of clinical trial,market demand,and adaptability in productive process are key factors in new drug RD.By means of analysis and discussion on these problems,we hope to enhance the efficiency and success rate of new drug RD while providing consults for relevant drug researches.

关 键 词：新药研发 三维模式 转换研究 临床研究 成药性 

分 类 号：R28[医药卫生—中药学]