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-ran...

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Bibliographic Details
Published in:Pharmaceutical research 2009-12, Vol.26 (12), p.2551-2557
Main Authors: Cunliffe, Jo, Derbyshire, Nicola, Keeler, Sue, Coldwell, Ruth
Format: Article
Language:English
Subjects:
Analysis
Biochemistry
Biomarkers
Biomarkers - analysis
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Flow cytometry
Flow Cytometry - methods
Flow Cytometry - standards
Guidelines
Medical Law
Opinion
Pharmaceutical sciences
Pharmacology/Toxicology
Pharmacy
Validation Studies as Topic
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Summary: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.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-009-9972-5