Show simple item record

dc.contributor.authorCummings, Jeffrey
dc.contributor.authorRaynaud, F
dc.contributor.authorJones, L
dc.contributor.authorSugar, R
dc.contributor.authorDive, Caroline
dc.date.accessioned2010-11-17T15:41:58Z
dc.date.available2010-11-17T15:41:58Z
dc.date.issued2010-10-26
dc.identifier.citationFit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. 2010, 103 (9):1313-7 Br J Canceren
dc.identifier.issn1532-1827
dc.identifier.pmid20924371
dc.identifier.doi10.1038/sj.bjc.6605910
dc.identifier.urihttp://hdl.handle.net/10541/115721
dc.description.abstractClinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the fit-for-purpose approach has recently been developed. This minireview focuses on many of the basic issues surrounding validation of biomarker assays utilised in clinical trials. It also provides an overview on strategies to validate each of the five categories that define the majority of biomarker assays.
dc.language.isoenen
dc.subjectBiomarkersen
dc.subjectValidationen
dc.subjectClinical Trialsen
dc.titleFit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs.en
dc.typeArticleen
dc.contributor.departmentClinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Wilmslow Road, Manchester M20 4BX, England. jcummings@picr.man.ac.uken
dc.identifier.journalBritish Journal of Canceren
html.description.abstractClinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the fit-for-purpose approach has recently been developed. This minireview focuses on many of the basic issues surrounding validation of biomarker assays utilised in clinical trials. It also provides an overview on strategies to validate each of the five categories that define the majority of biomarker assays.


This item appears in the following Collection(s)

Show simple item record