方法确认（PPT 61页）.ppt

Method Validation方法确认 Method Validation - Objectives方法确认 – 目标 By the end of this session you will be able to通过学习你将能够: Evaluate a new method with respect to what type of validation data are required获取相关确认数据，对新方法进行评估 Assess validation data to determine specific requirements that must be met for the validation to be verified and accepted评价确认数据，以确定方法确认应满足的特定要求已经验证并可接受 Presentation Outline报告讲述要点 Definitions and ISO 17025 requirements相关定义及ISO 17025 要求 Validation process方法确认过程 Examples of validation procedures方法确认举例 Parameters to be calculated参数计算 LOD, LOQ, precision, accuracy, uncertainty检出限定量限, 精密度, 准确度, 不确定度 QA verification of data数据验证的质量保证 What is a Method何谓方法? An analytical method is to be regarded as the set of written instructions completely describing the procedure to be adopted by the analyst in order to obtain the required analytical result.分析方法是一套书面说明,完整描述分析人员为获得所需要的分析结果所采用程序。1 1Wilson, A.L. “The Performance Characteristics of Analytical Methods-I” (1970) Talanta 17, 21-29 What is Method Validation何谓方法确认? Validation is the process of determining the suitability of methodology for providing useful analytical data.方法确认是确定方法能够提供有效分析数据的过程。 2 2 Taylor, J.K. “Validation of Analytical Methods” (1983) Anal. Chem. 55, 600A-608A ISO 17025: Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.方法确认是通过检查和提供客观证据确证某一特定用途的特殊要求已得到满足3 3 ISO 17025 Standard, element Objective of Method Validation方法确认的目标 应具有 合理设计的, 充分研究的, 形成完整文件的 分析方法 能为既定领域提供有用的数据 Sequence of Events方法确认工作的顺序: The process is not necessarily linear – it may be necessary to cycle back through method development at least once before the method can be successfully validated. 方法确认不一定是直线进程– 它可能需要随着方法的开发至少重复一次直到方法成功确认. General Classification of Method Validation Studies方法确认的分类 Interlaboratory (between laboratories)实验室间 At least two independent laboratories involved至少两个独立实验室 Sponsored by profess