单克隆抗体药物临床前动物实验研究技术风险评估
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摘要
在对单克隆抗体药物临床前动物实验研究技术风险来源进行准确识别的基础上,构建由3个基本因素、16个指标组成的单克隆抗体药物临床前动物实验研究技术风险评估指标体系。对60位相关专家和业内人士进行访谈和问卷调查,获取风险发生概率值和风险影响程度值。利用层次分析法计算风险指标权重,利用风险矩阵法计算风险指标风险值,并确定风险指标的风险等级,最后根据风险评估结果提出风险控制策略。
This research aimed at accurately identifying the risk sources involved in preclinical animal experiments which are conducted with monoclonal antibody drugs. Based on the findings of the research,the index system of bio-technology risk evaluation was constructed,which includes three fundamental factors and 16 indicators.With 60 experts and colleagues interviewed,a questionnaire was used to determine the probability of risk and its impact. The risk index weight was calculated by using the analytic hierarchy process,and the risk value of risk indicators was calculated by using the risk matrix. Thus,the risk level of the risk indicators was determined.Consequently,the risk control strategy was put forward according to the risk assessment results.
This research aimed at accurately identifying the risk sources involved in preclinical animal experiments which are conducted with monoclonal antibody drugs. Based on the findings of the research,the index system of bio-technology risk evaluation was constructed,which includes three fundamental factors and 16 indicators.With 60 experts and colleagues interviewed,a questionnaire was used to determine the probability of risk and its impact. The risk index weight was calculated by using the analytic hierarchy process,and the risk value of risk indicators was calculated by using the risk matrix. Thus,the risk level of the risk indicators was determined.Consequently,the risk control strategy was put forward according to the risk assessment results.
引文
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[16]姜爱萍,李喜凤,刘欣.基于风险矩阵法与Borda序值法的房地产信托风险评估[J].西部金融,2015(8):21-23.
[2]赵舒.单抗六强企业拥八成市场[N].医药经济报,2017-12-14(6).
[3]马金玲,孙云霞.单克隆抗体药物的临床前安全性评价[J].中国药理学与毒理学杂志,2013,27(3):509.
[4]国家食品药品监督管理总局.药品注册管理办法(局令第28号)[S].2007.
[5]JACOBSON-KRAM D,MILLS G.Leveraging exploratory investigational new drug studies to accelerate drug development[J].Clin Cancer Res,2008,14(12):3670-3674.
[6]于永辉.生物制品仿制研发风险管理研究[D].济南:山东大学,2014:5.
[7]COLVIN M,MARAVELIAS CT.R&D pipeline management:Task interdependencies and risk management[J].Eur J Oper Res,2011,215(3):616-628.
[8]金泉源.新药研发项目风险管理研究[D].沈阳:沈阳药科大学,2006:1-5.
[9]张波.新药研发项目的风险管理研究[D].无锡:江南大学,2007:1-3.
[10]周硕,徐琳,芮国忠.新药研发项目风险评价指标体系研究进展[J].中国医药技术经济与管理,2008,2(4):71-76.
[11]车越,何珊,陈玉文.生物药物研发项目中的技术风险分析[J].中国药业,2014,23(20):17-19.
[12]VULTO AG.Risk management of biosimilars in oncology[J].Oncologie,2011,13(5):196-200.
[13]邵荣光,甄永苏.抗体药物研究与应用[M].北京:人民卫生出版社,2013:512-513.
[14]曹茂林.层次分析法确定评价指标权重及Excel计算[J].江苏科技信息,2012,29(2):39-40.
[15]洪志国,李炎,范植华,等.层次分析法中高阶平均随机一致性指标(RI)的计算[J].计算机工程与应用,2002,38(12):45-47.
[16]姜爱萍,李喜凤,刘欣.基于风险矩阵法与Borda序值法的房地产信托风险评估[J].西部金融,2015(8):21-23.