浅析生物等效性试验风险管理策略  

Analysis on risk management strategy of bioequivalence study

作　　者：程晓华[1] 张红[2] 白薇[1] 李蒲[1] 段舟萍[1] 刘小健[1] 曹端文 胡锦芳[1] CHENG Xiao-hua;ZHANG Hong;BAI Wei;LI Pu;DUAN Zhou-ping;LIU Xiao-jian;CAO Duan-wen;HU Jin-fang(Institution of Drug Clinical Trial,the First Affiliated Hospital of None hang University,None hang JIANGXI 330006,China;Institution of Clinical Pharmacology,Norte hang University,None hang JIANGXI 330006,China)

机构地区：[1]南昌大学第一附属医院国家药物临床试验机构,江西南昌330006 [2]南昌大学临床药理研究所,江西南昌330006

出　　处：《中国新药与临床杂志》2019年第11期661-664,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家十二五“重大新药创制”科技重大专项(2011ZX09302-007-03)

摘　　要：仿制药一致性评价推动着生物等效性试验的开展,生物等效性试验的风险日益突出。本文基于临床试验管理者的视角,对生物等效性试验实施过程中的机构组织管理、受试者管理、试验药物和生物样品管理风险现状及存在问题进行剖析,提出加强对机构管理者及研究者生物等效性试验专业知识和法规的培训、关注受试者招募合规性及试验期间管理的合理性、规范试验药物和生物样品的管理流程和记录等相应的风险管控措施和策略。The consistency evaluation of generic drugs has promoted the development of bioequivalence study. The risks in bioequivalence study are increasingly prominent. From the perspective of clinical trial managers, the current risk status and existing problems of organization management, subject management,investigated products and biological sample management during the implementation of bioequivalence study were analyzed in this paper. Risk management measures and strategies were proposed, such as strengthening the training of bioequivalence professional knowledge and regulations on institutional manager and investigator,paying attention to the recruitment of subjects and the rationality of subject management during the trial, and standardizing the management process and record of investigated products and biological samples.

关 键 词：临床试验 生物等效性 质量控制 风险调节 

分 类 号：R95[医药卫生—药学]