Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro / In Vivo Correlations (Wiley Series on Technologies for the Pharmaceutical Industry)

Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed. The importance of biomarkers in translational medicine / Joseph Fleishaker Fit for purpose validation of biochemical assays : challenges and solutions / Gabriella Szekely-Klepser and Scott Fountain Transcriptional profiling in biomarker discovery / Michael E. Burczynski ... [et al.] Proteomic biomarker approaches in drug discovery and development / Ruth A. Vanbogelen, Jeffrey D. Thomas, and Diane Alessi Application of metabolomics to pharmaceutical research and development / Qiuwei Xu and William H. Schaefer Vascular biomarkers and imaging studies / Karin Potthoff, Ulrike Fiedler, and Joachim Drevs Cardiovascular biomarkers as examples of success and failure in predicting safety in humans / Simon Authier ... [et al.] Use of molecular imaging for receptor occupancy decision making in drug development / R. Paul Maguire Biosensors for clinical biomarkers / Sara Tombelli and Marco Mascini US regulatory perspective on biomarker development / Rajnikath Madabushi, Lawrence Lesko, and Janet Woodcock EU regulatory perspective on biomarkers / Ian Hudson Use of biomarkers in drug development : Japanese perspectives / Yoshiaki Uyama ... [et al.] In vitro-in vivo correlations of hepatic drug clearance / R. Scott Obach The potential of in silico and in vitro approaches to predict in vivo drug-drug interactions and ADMET/TOX properties / Kenneth Bachmann and Sean Ekins In vitro-in vivo correlations in drug discovery and development : concepts and applications in toxicology / Rex Denton, Kimberly Brannen, and Buce D. Car Assessing the potential for induction of cytochrome P450 enzymes and predicting the in vivo response / Jiunn H. Lin. __Practical Utility of Biomarkers in Drug Discovery and Development__