【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。更多还原

【Abstract】 With the previous experiences and lessons,standardizing pharmaceutical activities,espe- cially 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.更多还原