生物药物研发项目中的技术风险分析  

Technical Risks in Research and Development Project of Biological Drug

作　　者：车越[1] 何珊[1] 陈玉文[1] 

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国药业》2014年第20期17-19,共3页China Pharmaceuticals

基　　金：科技部"十二五"重大新药创制国家科技重大专项;项目编号:2013ZX09301305

摘　　要：目的识别生物药物研发风险,为生物新药研发项目风险管理提供参考。方法生物药物研发过程可划分为实验室研究阶段、临床前研究阶段和临床试验研究阶段,根据3个阶段的不同特点,对生物药物研发的技术风险进行阐述。结果 3个环节都存在不同的技术风险,实验室阶段集中于技术不成熟和技术的创新能力不足,临床前研究阶段主要集中在生物药物的药物效应学、药代动力学和毒理学的风险,临床试验阶段主要集中于试验设计和临床机构。结论生物药物研发不同环节的技术风险影响着研发项目的进行,识别技术风险有利于为生物药物研发项目风险控制提供策略和参考。Objective To recognize the risks of biological drug research and development（R ＆ D） to provide reference for the risk management of the biological drug R ＆ D project. Methods The biological drug R ＆ D process can be divided into the laboratory research stage,preclinical study stage and clinical trials stage,according to the different characteristics of the three stages,the technical risk of biological drug R ＆ D was elaborated. Results The different technical risks exist in three links,which in the laboratory re-search stage is concentrated on the immature technique and insufficient technical innovation capability;which in the pre-clinical re-search stage is focused on the risks of biological drug pharmacodynamics,pharmacokinetics and toxicology and which in the clinical tri-als stage is focused on the clinical trial design and clinical organization. Conclusion The technical risks in different links of R ＆ D project affect the process of R ＆ D project,recognizing the technical risks is conducive to provide the strategy and reference for con-trolling the risk of biological drug R ＆ D project.

关 键 词：生物药物 研发项目 风险管理 

分 类 号：R954[医药卫生—药学]