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From research to regulated: challenges in transferring methods

From research to regulated: challenges in transferring methods
From research to regulated: challenges in transferring methods
The current decade has seen an evolution in biomarker research, with a breakthrough from traditional single analyte studies to simultaneous multiple analyte technologies, aided by the progressive development of research tools and the discovery of many novel biomarkers. It is foreseeable that the application of such technologies will have an integral role in clinical studies for establishing biomarker profiles of disease status and prognosis. However, the transfer of such complex procedures to a regulated environment presents many obstacles. Here, we discuss some of these applied technologies and the validation approaches we have taken as an academic unit to prove their suitability and appropriateness for clinical application. We discuss the advantages and limitations for such end point assays in early Phase clinical trials
1757-6180
285-291
Chowdhury, Ferdousi
0af499d4-17c5-40cf-9426-0d509ab82595
Williams, Anthony P.
973ff46f-46f1-4d7c-b27d-0f53221e4c44
Chowdhury, Ferdousi
0af499d4-17c5-40cf-9426-0d509ab82595
Williams, Anthony P.
973ff46f-46f1-4d7c-b27d-0f53221e4c44

Chowdhury, Ferdousi and Williams, Anthony P. (2009) From research to regulated: challenges in transferring methods. Bioanalysis, 1 (2), 285-291. (doi:10.4155/bio.09.51).

Record type: Article

Abstract

The current decade has seen an evolution in biomarker research, with a breakthrough from traditional single analyte studies to simultaneous multiple analyte technologies, aided by the progressive development of research tools and the discovery of many novel biomarkers. It is foreseeable that the application of such technologies will have an integral role in clinical studies for establishing biomarker profiles of disease status and prognosis. However, the transfer of such complex procedures to a regulated environment presents many obstacles. Here, we discuss some of these applied technologies and the validation approaches we have taken as an academic unit to prove their suitability and appropriateness for clinical application. We discuss the advantages and limitations for such end point assays in early Phase clinical trials

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Published date: May 2009

Identifiers

Local EPrints ID: 157333
URI: https://eprints.soton.ac.uk/id/eprint/157333
ISSN: 1757-6180
PURE UUID: 347f5cc6-58ec-47e8-9b0b-414e2fe95572

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Date deposited: 04 Jun 2010 14:14
Last modified: 16 Jul 2019 23:56

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