UNC-Chapel Hill ENVR 442 - Strategic paths for biomarker qualification (5 pages)

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Strategic paths for biomarker qualification



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Strategic paths for biomarker qualification

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Pages:
5
School:
University of North Carolina at Chapel Hill
Course:
Envr 442 - Biochemical and Molecular Toxicology
Biochemical and Molecular Toxicology Documents

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Available online at www sciencedirect com Toxicology 245 2008 219 223 Strategic paths for biomarker qualification Federico M Goodsaid a Felix W Frueh a William Mattes b a Genomics Group Of ce of Clinical Pharmacology Of ce of Translational Science Center for Drug Evaluation and Research FDA United States b Critical Path Institute Received 13 November 2007 accepted 17 December 2007 Available online 6 January 2008 Abstract Biomarkers may be qualified using different qualification processes A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker Active strategies for qualification include those associated with context independent as well as context dependent qualifications 2007 Elsevier Ireland Ltd All rights reserved Keywords Biomarkers Consortia 1 Introduction Several definitions have been published for what a biomarker is Lesko and Atkinson 1999 Lee et al 2006 and also for how to qualify exploratory biomarkers Goodsaid and Frueh 2006 Wagner et al 2007 The focus of this review is on strategies developed to qualify biomarkers and how these strategies are encouraging new biomarkers in drug development Independently of the definitions we use for biomarkers and their qualification the urgent need to improve tools available to accelerate development of new and better drugs Orr et al 2007 Goodsaid and Frueh 2007a is reflected in the intensive research on biomarkers within the pharmaceutical industry and in academic and government labs Biomarker use requires some level of biomarker consensus whether this consensus is generated internally within pharmaceutical companies for internal decision making or externally among scientists and clinicians Acceptance of biomarkers has often not been linked to a comprehensive



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