Predictive approaches in drug discovery and development: biomarkers and in vitro / in vivo correlations

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 andunsuccessful 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. INDICE: PrefaceAcknowledgmentsContributorsPart I: Biomarkers in Drug Discovery1.The Importance of Biomarkers in Translational MedicineJoseph Fleishaker2. Fit for Purpose Validation of biochemical assays - challenges and solutionsGabriella Szekely-Klepser and Scott Fountain3. Trancriptional Profiling in Biomarker DiscoveryMichael E. Burczynski, Edward R. Lavallie, Christina M. Coughlin and Andrew J. Dorner4. Proteomic Biomarker Approaches in Drug Discovery and DevelopmentRuth A. Vanbogelen, Jeffrey D. Thomas and Diane Alessi5. Application of Metabolomics to Pharmaceutical Research and DevelopmentQiuwei Xu and William H. SchaeferPart II. Clinical Application of Biomarkers6. Vascular Biomarkers and Imaging StudiesKarin Potthoff, Ulrike Fiedler, and Joachim Drevs7. Cardiovascular Biomarkers as examples of Success and Failure in Predicting Safety in HumansSimon Authier, Michael K. Pugsley, Eric Troncy and Michael J. Curtis8. Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug DevelopmentR. Paul Maguire9. Biosensors for Clinical BiomarkersSara Tombelli and Marco MasciniPart III. Regulatory Perspectives10. US Regulatory Perspective on Biomarker DevelopmentRajnikath Madabushi, Lawrence Lesko and Janet Woodcock11.EU Regulatory Perspective on BiomarkersIan Hudson12. Use of biomarkers in Drug Development - Japanese PerspectivesYoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura and Satoshi ToyoshimaPart IV. Predicting In Vivo13. In Vitro-In Vivo Correlations of Hepatic Drug ClearanceR. Scott Obach14. The Potential Of In Silico and InVitro Approaches To Predict In Vivo Drug-Drug Interactions and ADMET/TOX PropertiesKenneth Bachmann and Sean Ekins15. In Vitro-In Vivo Correlations in Drug Discovery and Development: Concepts and Applications in ToxicologyRex Denton, Kimberly Brannen, and Buce D. Car16. Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo ResponseJiunn H. Lin

• ISBN: 978-0-470-17083-0
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 408
• Fecha Publicación: 04/05/2012
• Nº Volúmenes: 1
• Idioma: Inglés