摘要
方法确认是保证所用分析方法达到其预期使用目的重要过程和内容。因为该概念及其相应理论的发展与完善关乎所确认的实验方法的可靠性和公认性,所以人们对该领域越来越重视。本文对近5年来关于方法确认相关内容的最新研究进展进行概述,主要包括:引入方法的"生命周期(lifecycle)"和"质量源于设计(quality by design,Qb D)"的理念,拓展了现有的"确认(validation)"概念。根据"分析目标概貌(analytical target profile,ATP)"理念和相关理论,重新整理并给出各参数确认的标准。针对方法确认所规定的参数,配套建立起对应的各参数满足标准的统计计算方法,并阐述了计算原理。阐述了一些表述不准确或不必要的参数(如linearity、LOQ)。针对生物活性测定方法的特殊性,建立起单独的确认指导原则。对新方法替代法定方法,提出"等效或优于"的相关统计比较原则。
Procedure validation is a very important process to confirm that the analytical procedure can fulfil its intended use. People are paying more and more attention to the development and improvement of the term＂validation＂and its theory system because it is closely related to the reliability and legibility of the procedure.Herein,we summarized the progress in last five years in the following aspects： enriching / enlarging the denotation of＂procedure validation＂term by introducing the idea of lifecycle and the theory of Qb D; reorganizing the validation parameters and set up the acceptance criteria for them according to the theory of Analytical Target Profile and related statistics; supplementing statistical tools for parameter calculation and elucidating the calculation principle; giving the reasons why some parameters that are not accurate expressed or necessary,such as LOQ and linearity; developing the individual guidance for bioassay according to its specialty; promoting the ＂equivalent or better＂comparison rule when a new procedure substitues an official procedure
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第9期985-990,共6页
Chinese Journal of New Drugs
基金
国家十二五"重大新药创制"科技重大专项(2015ZX09303001)
