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Implementation of highly sophisticated flow cytometry assays in multi- center clinical studies: considerations and guidance

Sommer, Ulrike, Morales, Johanna, Groenewegen, Andrea, Mueller, Annemarie, Naab, Julia, Woerly, Gaetane, Kamphausen, Esther, Marsot, Helene, Bennet, Patrick, Kakkanaiah, Vellalore and Vitaliti Garami, Alessandra (2015) Implementation of highly sophisticated flow cytometry assays in multi- center clinical studies: considerations and guidance. Bionalysis, Vol. 7 (No. 10). pp. 1299-1311. ISSN DOI 10.4155/bio.15.61

Abstract

the item has no formal formal abstract
as summary of the items the table of contents is given here:
Table of contents
1 Introduction:
1.1 Technical overview and applications of flow cytometry
1.2 Use of flow cytometry for biomarker analysis in human clinical studies
2 Development and Validation of flow cytometry assays for clinical use
2.1 Summary of key challenges
2.2 Considerations for the Validation of PhosFlow assays used for PK/PD assessment
3 Whole blood flow cytometry assays in multi-center clinical studies:
Immunophenotyping versus PhosFlow
3.1 On-site processing of whole blood samples
3.2 Stabilization of samples: stabilizing tubes or freezing of whole blood samples
3.3 Clinical study implementation
4 Summary and Future Perspectives:

Item Type: Article
Keywords: Flow cytometry, biomarkers, validation, clinical trial
Date Deposited: 12 Oct 2016 00:45
Last Modified: 12 Oct 2016 00:45
URI: https://oak.novartis.com/id/eprint/24612

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