Predictive Approaches in Drug Discovery and Development

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Comprehensive coverage of biomarker research applied to drug discovery and development Two key factors have emerged in the race to discover approvable new drugs faster and with fewer resources: biomarkers and in vitro/in vivo correlations (IVIVC). Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro/In Vivo Correlations provides comprehensive coverage of how these factors are enhancing the drug pipeline and accelerating development. An invaluable resource, the book presents essential information on the importance of biomarkers in translational medicine, the clinical applications of biomarkers, relevant regulatory perspectives, and the potential of in vivo research. With each chapter written by one or more expert authors from the global front lines of the pharmaceutical industry and regulatory agencies, the book also incorporates academic research that unites these two fields and describes their applications, from technical lab experiments to strategic management. Covering many aspects of biomarker research as applied to drug discovery and development, the book brings together state-of-the-art appraisals of the practical utility of "-omics", biochemical, and protein biomarkers with case histories and lessons from successful and unsuccessful real-world applications. Regulatory agency perspectives and initiatives in the United States and around the world are also discussed, as are GLP validation and, safety biomarkers, and proteomic biomarkers. Biomarkers and IVIVC present unique opportunities for identifying more robust clinical candidates and selecting leads more intelligently, making Predictive Approaches in Drug Discovery and Development a must-have for researchers and professionals in the pharmaceutical and biotechnology industries, as well as for use in advanced graduate and undergraduate courses.