Biomarkers in Clinical Drug Development

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