本文介绍了药物非临床研究的内容及意义,分析了药物非临床研究风险管理内涵与风险构成,建立了药物非临床研究风险管理流程。药物非临床研究者可以通过严格遵守GLP规范、确定合理的实验方案、建立高度匹配的动物模型、选取适合的参比药物、采用新方法和新技术、建立完善的沟通机制等措施规避非临床研究风险。 This paper introduces the content and significance of non-clinical research, analyzes the connotation and risk structure of risk management of non-clinical research, and establishes the risk management process of non-clinical research. Nonclinical investigators can avoid nonclinical studies by strictly following the GLP guidelines, establishing rational protocols, establishing highly matched animal models, selecting appropriate reference drugs, adopting new methods and techniques, and establishing sound communication mechanisms risk.