Comprehensive coverage of biomarker research applied to drugdiscovery and development
Two key factors have emerged in the race to discover approvablenew drugs faster and with fewer resources: biomarkers and invitro/in vivo correlations (IVIVC). Predictive Approaches in DrugDiscovery and Development: Biomarkers and In Vitro/In VivoCorrelations provides comprehensive coverage of how these factorsare enhancing the drug pipeline and accelerating development.
An invaluable resource, the book presents essential informationon the importance of biomarkers in translational medicine, theclinical applications of biomarkers, relevant regulatoryperspectives, and the potential of in vivo research. With eachchapter written by one or more expert authors from the global frontlines of the pharmaceutical industry and regulatory agencies, thebook also incorporates academic research that unites these twofields and describes their applications, from technical labexperiments to strategic management.
Covering many aspects of biomarker research as applied to drugdiscovery and development, the book brings togetherstate-of-the-art appraisals of the practical utility of "-omics",biochemical, and protein biomarkers with case histories and lessonsfrom successful and unsuccessful real-world applications.Regulatory agency perspectives and initiatives in the United Statesand around the world are also discussed, as are GLP validation and,safety biomarkers, and proteomic biomarkers.
Biomarkers and IVIVC present unique opportunities foridentifying more robust clinical candidates and selecting leadsmore intelligently, making Predictive Approaches in Drug Discoveryand Development a must-have for researchers and professionals inthe pharmaceutical and biotechnology industries, as well as for usein advanced graduate and undergraduate courses.
“The ability to correlate in vitro and in vivo biomarkerinformation in the process of drug discovery and development liesat the heart of translational research. The goal is to rapidlytranslate basic discoveries into clinical applications. This bookprovides state-of-the-art information on this exciting new researchapproach.” (Doody’s, 8 February 2013)
“The text is packed with interesting, comprehensive, andpertinent information, clearly presented with salient pointsreinforced by inclusion in text boxes . . . This is an admirabletextbook for those dealing with drug discovery and development. Ienjoyed reading through it and I would recommend it to anyone whohas an interest, or is developing an interest, in the field ofbiomarkers and their, as yet, unfulfilled potential.” (ISSX International Society for the Study of Xenobiotics, 1December 2012)