摘要
随着生物技术的不断发展,有越来越多的基因治疗药物申请进行临床试验。尽管总的发展趋势令人充满期待,但这类产品在技术、伦理道德以及安全性等方面仍然存在许多问题。本文综述了基因治疗药物的研发和监管现状,探讨我国在基因治疗药物注册审批和监管中还有待解决的问题。
With the development of biological technology,more and more gene therapy medicinal products were applied for clinical trials.Despited the encouraging trend,there were still several issues involving technical method,ethic,and safety need to be dealt with.This paper reviews the development and management status of gene therapy medicinal products,and discusses its strategies on registration,evaluation and supervision in China.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2011年第3期172-175,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
基因疗法
生物技术
开发
组织状况研究
gene therapy
biotechnology
development
organizational case studies
