生物标志物在药品生命周期中的应用与相关法规  

Application of biomarkers in life cycle of drugs and related regulations

作　　者：谢媛媛[1] 张涛[2] 贺浪冲[2] 宋宗华[3] 罗国安[1] XIE Yuanyuan;ZHANG Tao;HE Langchong;SONG Zonghua;LUO Guoan(Department of Chemistry,Tsinghua University,Beijing 100084,China;School of Pharmacy,Xi′an Jiaotong University,Xi′an 710061,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]清华大学化学系,北京100084 [2]西安交通大学药学院,西安710061 [3]国家药典委员会,北京100061

出　　处：《中国药品标准》2020年第2期89-97,共9页Drug Standards of China

基　　金：国家自然科学基金重点基金(81130066,81230079);面上项目(81473174);国家药典委员会药品标准制修订研究课题(2019Y12)。

摘　　要：生物标志物(biomarker)是一种能客观测量并评价正常生物过程、病理过程或对药物干预反应的指示物,可有效提高新药研究开发决策,指导候选药物早期临床试验,降低新药研发失败的风险。其在新药开发与临床治疗中的关键作用受到世界各国(地区)的关注,纷纷出台相应的支持政策。本文通过对生物标志物的定义与分类、各国对生物标志物在药品研究开发中应用的政策法规以及生物标志物分析检测技术规范等进行分析和综述,提出和制订《药物生物标志物分析检测验证技术指导原则》(草案),提交国家药典委员会,以期为生物标志物的发现、检测、验证及其在医药行业的应用提供技术指导。Biomarkers which was defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes,pathogenic processes,or pharmacologic responses to a therapeutic intervention.Biomarkers can help the decision-making of new drug research and development,and provide guidance for the early clinical development of candidate drugs,and reduce the risk of failure.Therefore,as one of key influencing factors to promote the development potency of new drug,the discover and research of biomarker had cause the extensive concern of the pharmaceutical industry and regulatory department.The definition and classification of biomarkers,the related guidelines and regulations about the application of biomarkers in different countries,as well as the technical specifications about the detection of biomarkers had been analyzed and summarized here.Then“drug biomarker analysis verification technology guidelines”(draft)was put forward and being submitted to China pharmacopoeia committee for auditing,in order to provide related technology director for the discover,determination,verification and application of biomarker in medical industry.

关 键 词：生物标志物 药品生命周期 新药研发 药品质量 法规 

分 类 号：R921.2[医药卫生—药学]