采用Westgard性能评价图和Sigma指标对Ⅰ期临床试验实施质控  

Quality control in phase Ⅰ clinical trial by applying Westgard figure of performance and six Sigma indexes

作　　者：王健康[1] 董晓莉[1] 张福成[1] 

机构地区：[1]解放军空军总医院药学部,北京100142

出　　处：《中国新药杂志》2011年第7期582-586,共5页Chinese Journal of New Drugs

摘　　要：目的:采用Westgard性能评价图和Sigma指标对Ⅰ期临床试验实施质控,以发现问题,指导质量改进。方法:采用本实验室检测项目吗替麦考酚酸酯胶囊数据,分别绘制其方法学和随行质控的Westgard性能评价图,并计算二者的Sigma值和QGI值,用来评价其性能和选择适当的质量控制标准。结果:根据检测物自身特点,吗替麦考酚酸酯胶囊方法学质控标准选择为3个浓度操作点应控制在3 Sigma以内;随行质控标准选择为每个检验批次数据操作点均应控制在2 Sigma以内。结论:采用Westgard性能评价图和Sigma指标,可以对Ⅰ期试验研究室所建立的方法学和随行质控性能进行正确评估,可以建立恰当的随行质控标准,实现Ⅰ期临床试验的质量控制。Objective： To execute quality control in phase Ⅰ clinical trial by applying Westgard figure of performance and 6 Sigma indexes for finding out problems and promoting quality improvement.Methods： Data of mycophenolate mofetil capsule were collected from our laboratory.The performance Westgard figure for methodological and homochronous quality control were drawn.Ⅰts Sigma values and the QGⅠ were calculated to estimate performance of the methodology and choose control standardization of optimum quality.Results： According to the properties of mycophenolate mofetil,the control standardization for methodological quality was based on 3 points of concentrations in 3 Sigma areas.The control standardization for homochronous quality was based on each batch operation point in 2 Sigma areas.Conclusion： Westgard figure of performance and 6 Sigma indexes can correctly estimate the methodological and homochronous quality control in phase Ⅰ trial,and the optimum quality control standardization can be chosen.The methodology is useful for executing quality control in phase Ⅰ clinical trial.

关 键 词：Ⅰ期临床试验 6 SIGMA 质量控制 质量改进 

分 类 号：R95[医药卫生—药学] R969.4