摘要
目的:介绍在色谱分析方法中方法学验证与质控的内容及其有待发展的方向。方法:参阅国际上有关方法学验证的指导原则、国家食品药品监督管理局管理规范,结合本实验室的标准操作规程,对方法学验证与质控的内容及存在的问题进行综合分析。结果:总结了方法学验证和质控的内容,及方法学验证中存在的可能的风险。结论:已建立的方法学验证和质控内容基本完善,但方法学验证的标准也应该根据实际情况制定。
OBJECTIVE： To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development. METHODS： According to the bioanalytieal validation reflected in FDA guidelines and other publications, based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab, we sum- marized the procedure and questions of bioanalytical methodology validation. RESULTS： The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology Validation were summarized. CONCLUSIONS： The established methodology validation in bioanalytieal procedure and quality control contents were basically consummate, but the standards for the methodology validation should be formulated based on reality.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第31期2469-2471,共3页
China Pharmacy
关键词
生物样品分析
方法学验证
方法学质控
Bioanalysis
Methodology validation
Methodology quality control
