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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 assess the quality of Phase I clinical trials using Westgard performance evaluation and Sigma indicators to identify problems and guide quality improvement. METHODS: Using our laboratory test kit for mycophenolate mofetil capsules, the Westgard performance maps of their methodologies and accompanying controls were plotted and their Sigma and QGI values were calculated for evaluation of their performance and Choose the appropriate quality control standard. Results: According to the characteristics of the test substance, the quality control standard of mycophenolate mofetil capsules should be controlled within 3 Sigma for the three concentration operation points; the quality control standard should be selected as the operation point of each test lot data Should be controlled within 2 Sigma. Conclusion: The Westgard performance evaluation map and the Sigma index can be used to evaluate the methodology and quality control performance of the phase Ⅰ laboratory. The appropriate quality control standards can be established to achieve the quality control of Phase Ⅰ clinical trials.