基于Q2(R1)理念的药品质量分析方法验证新概念  

Analysis to New Concept of Drug Quality Methods Validation Based on Concept of Q2(R1)

作　　者：沈秋月[1] 张真庆[1] 

机构地区：[1]苏州大学药学院,江苏苏州215000

出　　处：《抗感染药学》2016年第3期496-499,共4页Anti-infection Pharmacy

摘　　要：分析方法验证的目的是证明采用的方法适合于检测用途。新的方法验证对各个验证参数同时进行评估,引入了总误差概念,给将来的任何一个单个测试结果落在一定置信区间的可接受标准之内提供证据并核实,使得验证后的方法更具可信度。概括和介绍了新的分析方法验证的目的、实验设计、优点和应用等方面的内容,以帮助大家了解这种分析方法验证的新概念。The purpose of the method validation is to demonstrate that the analytical method is suitable fur its in- tended use. The new method validation evaluates the validation parameters simultaneously, introduces total error; pro- vide evidence that any future single result will be left within acceptable limits with some level of confidence and verify it. It will enhance the method reliability. A new analytical method validation was summarized and introduced, including the purpose, experimental design, benefit and use of the new method validation, to help people to understand the new concept of the method validation.

关 键 词：Q2(R1) 药品质量 方法验证 新概念 

分 类 号：R927.1[医药卫生—药学]