一种流式细胞术方法的验证方法。

IF 3.5 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Pharmaceutical Research Pub Date : 2009-12-01 Epub Date: 2009-10-14 DOI:10.1007/s11095-009-9972-5
Jo Cunliffe, Nicola Derbyshire, Sue Keeler, Ruth Coldwell
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引用次数: 33

摘要

本出版物概述了流式细胞术方法在广泛的生物标志物分析中使用的验证方法。它是作为GLP环境中方法验证的指导性文件编写的,并且是从制药行业的角度来看,但它的相关性是广泛的。所描述的方法验证方法旨在作为进一步讨论的起点,并为开发适合目的的流式细胞术方法的同事提供参考材料。讨论预验证步骤,作为确定方法和试剂适用性的先决条件评估,并在整个验证过程中尽量减少变量。方法验证指南考虑了许多正在使用的流式细胞术检测类型,并提供了必要的评估类型指南,以产生适合在监管环境中使用的适合目的的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An approach to the validation of flow cytometry methods.

This publication outlines an approach for the validation of flow cytometry methods used in the analysis of a wide range of biomarkers. It is written as a guidance document for method validation in a GLP environment, and from the viewpoint of the pharmaceutical industry, but its relevance is wide-ranging. The approach to method validation described is intended as a starting point for further discussion, as well as providing reference material to colleagues developing fit-for-purpose flow cytometry methods. Pre-validation steps are discussed as prerequisite assessments to determine method and reagent suitability, and to minimise variables during the full validation process. The guide to method validation takes account of the many flow cytometry assay types in use, and provides guidance on the types of assessments necessary to produce a fit-for-purpose method suitable for use in a regulatory environment.

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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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