Buick A R, Doig M V, Jeal S C, Land G S, McDowall R D
Department of Bioanalytical Sciences, Wellcome Research Laboratories, Beckenham, Kent, UK.
J Pharm Biomed Anal. 1990;8(8-12):629-37. doi: 10.1016/0731-7085(90)80093-5.
Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to engender confidence in the results generated. The fundamental criteria for assessing the reliability and overall performance of a bioanalytical method are: the evaluation of drug and analyte stability, selectivity, limits of quantification and detection, accuracy, precision, linearity and recovery. The extent to which a method is validated is dependent on its prospective use, the number of samples to be assayed and the use to which the data are put. Specific analytical techniques may require additional validation such as antibody-binding characteristics, peak purity determination, evaluation of matrix effects or structural confirmation of the analyte. Ideally each assay should be cross-validated with a method utilizing a highly specific detector such as a mass spectrometer. Once in use, the performance of the method should be monitored using quality control standards. If a method is set up in another laboratory, the performance of that assay should be monitored with quality control standards sent from the originating laboratory.
基于各种物理化学和生物技术（如色谱法、免疫测定法和质谱法）的生物分析方法，在使用前和使用过程中必须进行验证，以确保对所产生结果的可信度。评估生物分析方法可靠性和整体性能的基本标准包括：药物和分析物稳定性评估、选择性、定量限和检测限、准确性、精密度、线性和回收率。方法验证的程度取决于其预期用途、待分析样品的数量以及数据的用途。特定的分析技术可能需要额外的验证，如抗体结合特性、峰纯度测定、基质效应评估或分析物的结构确认。理想情况下，每个分析方法都应与使用高特异性检测器（如质谱仪）的方法进行交叉验证。一旦投入使用，应使用质量控制标准监测方法的性能。如果在另一个实验室建立了一种方法，则应使用来自原始实验室的质量控制标准监测该分析方法的性能。
