Biomarkers in Clinical Drug Development

ISBN: 9780824740269 出版年：2003 页码：312 CRC Press

Biomarkers in clinical drug development - definitions and disciplines, John C. Bloom the clinical laboratory and collection of biomarker data, Gordon F. Kapke and Robert A. Dean using imaging biomarkers to demonstrate efficacy in clinical trials - trends and challenges, Charles G. Peterfy and Barbara Maley markers for cardiac repolarization and risk assessment, William J. Groh and Gregory D. Sides development and application of interspecies biomarkers in nonclinical safety evaluations, Frank D. Sistare validation of assays for the bioanalysis of novel biomarkers - practical recommendations for clinical investigation of new drug entities, Jean W. Lee, Gerald D. Norblom, Wendell C. Smith and Ronald R. Bowsher validation of biomarkers as surrogates for clinical endpoints, Marc Buyse, Tony Vangeneugden, Luc Bijnens, Didier Renard, Tomasz Burzykowski, Helena Geys and Geert Molenberghs biomarkers in pharmacokinetic/pharmacodynamic modelling and clinical trial simulation, Wayne Colburn pharmacogenomic biomarkers, Richard Hockett and Sandra Kirkwood quality assurance and regulatory compliance, Linda Knoob, Angela Berns and Jacqueline Hevy biomarkers strategies in drug development - striking a balance between opportunities and liabilities, Robert A. Dean partnerships on biomarker research, Gregory Downing clinical operations - business principles for biomarker applications, John C. Bloom.