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    Fit-for-purpose biomarker method validation in anticancer drug development.

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    Authors
    Cummings, Jeffrey
    Ward, Timothy H
    Dive, Caroline
    Affiliation
    Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Wilmslow Road, Manchester M20 4BX, England, United Kingdom.
    Issue Date
    2010-08-11
    
    Metadata
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    Abstract
    The introduction of new anticancer drugs into the clinic is often hampered by a lack of qualified biomarkers. Method validation is indispensable to successful biomarker qualification and is also a regulatory requirement. Recently, the fit-for-purpose approach has been developed to promote flexible yet rigorous biomarker method validation, although its full implications are often overlooked. This review aims to clarify many of the scientific and regulatory issues surrounding biomarker method validation and the analysis of samples collected from clinical trial subjects. It also strives to provide clear guidance on validation strategies for each of the five categories that define the majority of biomarker assays, citing specific examples.
    Citation
    Fit-for-purpose biomarker method validation in anticancer drug development. 2010: Drug Discov Today
    Journal
    Drug Discovery Today
    URI
    http://hdl.handle.net/10541/111375
    DOI
    10.1016/j.drudis.2010.07.006
    PubMed ID
    20708097
    Type
    Article
    Language
    en
    ISSN
    1359-6446
    EISSN
    1878-5832
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.drudis.2010.07.006
    Scopus Count
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