摘要
加强新药研发过程,尤其是早期研究阶段的规范化管理,能够将已有新药研发的经验和教训固化下来,从而有效地节约资源、加快新药研发的进程。在某种程度上降低了药物后续开发的风险,并为以后其他新药项目的研发工作提供借鉴。本文着重从研发工作流程和研发管理体系两个方面探讨早期新药研发活动如何进行规范化。
With tile previous experiences and lessons, standardizing pharmaceutical activities, especially in early stage, can save resources, improve R＆D process and reduce its risks. Also the result of this study would be very helpful for other new drug R＆D projects. This paper puts emphasis on the standard of new drug R ＆ D in early stage for both the process of R ＆D and management.
出处
《中华医学科研管理杂志》
2006年第4期212-214,共3页
Chinese Journal of Medical Science Research Management
关键词
新药研发
规范化
管理
Pharmaceutical R＆D
Standardization
Management
