Method Validation方法确认(ppt 61页)

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

..............................