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" Biomarkers in drug development : "
edited by Michael R. Bleavins [and others].
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BL
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| Record Number
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1005179
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b759549
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| Title & Author
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Biomarkers in drug development : : a handbook of practice, application, and strategy /\ edited by Michael R. Bleavins [and others].
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| Publication Statement
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Hoboken, N.J. :: John Wiley & Sons,, ©2010.
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| Page. NO
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xvii, 744 pages, 16 unnumbered pages of plates :: illustrations (some color) ;; 25 cm
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| ISBN
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0470169273
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: 9780470169278
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Biomarkers are not new -- Biomarkers : Facing the challenges at the crossroads of research and heath care -- Enabling go/no go decisions -- Imaging as a localized biomarker : Opportunities and challenges -- Protein biomarker discovery using mass spectrometry-based proteomics -- Quantitative multiplexed patterning of immune-related biomarkers -- Gene expression profiles as preclinical and clinical cancer biomarkers of prognosis, drug response, and drug toxicity -- Use of high-throughput proteomic arrays for the discovery of disease-associated molecules -- Characterization and validation biomarkers in drug development : Regulatory perspective -- Fit-for-purpose method validation and assays for biomarker characterization to support drug development -- Molecular biomarkers from a diagnostic perspective -- Strategies for the co-development of drugs nad diagnostics : FDA perspective on diagnostics regulation -- Importance of statistics in the qualification and application of biomarkers -- Qualification of safety biomarkers for application to early drug development -- Development of serum calcium and phosphorous as clinical biomarkers for drug-induced systemic mineralization : Case study with a MEK inhibitor -- Biomarkers for the immunogenicity of therapeutic proteins and its clinical consequences -- New markers of kidney injury -- Translational medicine--a paradigm shift in modern drug discovery and development : The role of biomarkers -- Clinical validation and biomarker translation -- Predicting and assessing an inflammatory disease and its complications : Example from rheumatoid arthritis -- Pharmacokinetic and pharmacodynamic biomarker correlations -- Validating in vitro toxicity biomarkers against clinical endpoints -- Opportunities and pitfalls associated with early utilization of biomarkers : Case study in anticoagulant development -- INtegrating molecular testing into clinical applications -- Biomarkers for lysosomal storage disorders -- Value chain in the development of biomarkers for disease targets -- Biomarkers in pharmaceutical development : The essential role of project management and teamwork -- Integrating academic laboratories into pharmaceutical development -- Funding biomarker research and development through the small business innovative research program -- Novel and traditional nonclinical biomarker utilization in the estimation of pharmaceutical therapeutic indices -- Anti-unicorn principle : Appropriate biomarkers don't need to be rare or hard to find -- Biomarker patent strategies : Opportunities and risks -- IT supporting biomarker-enabled drug development -- Redefining disease and pharmaceutical targets through molecular definitions and personalized medicine -- Ethics of biomarkers : The borders of investigative research, informed consent, and patient protection -- Pathodynamics : Improving biomarker selection by getting more information from changes over time -- Optimizing the use of biomarkers for drug development : A clinician's perspective -- Nanotechnology-based biomarker detection.
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| Abstract
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As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in transnational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine." "Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
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| Subject
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Biochemical markers.
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Drug development.
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Biochemical markers.
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Drug development.
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Biomarkers, Pharmacological.
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Drug Design.
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Drug Discovery.
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| Dewey Classification
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615/.10724
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| LC Classification
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R853.B54B5645 2010
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| NLM classification
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2010 C-719
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QV 744B6154 2010
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| Added Entry
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Bleavins, Michael R.
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