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Front MatterAbstract - Hi-Res PDF (609 KB) - PDF w/links (610 KB)
Chapter 1. Biomarkers in Clinical Drug DevelopmentAbstract - Hi-Res PDF (309 KB) - PDF w/links (312 KB)
Chapter 2. The Clinical Laboratory and Collection of Biomarker DataGordon F. KapkeAbstract - Hi-Res PDF (383 KB) - PDF w/links (381 KB)
Chapter 3. Using Imaging Biomarkers to Demonstrate Efficacy in Clinical TrialsCharles G. Peterfy, Barbara MaleyAbstract - Hi-Res PDF (1162 KB) - PDF w/links (1164 KB)
Chapter 4. Markers for Cardiac Repolarization and Risk AssessmentWilliam J. Groh, Gregory D. SidesAbstract - Hi-Res PDF (511 KB) - PDF w/links (508 KB)
Chapter 5. Development and Application of Interspecies Biomarkers in Nonclinical Safety EvaluationsFrank D. SistareAbstract - Hi-Res PDF (360 KB) - PDF w/links (370 KB)
Chapter 6. Validation of Assays for the Bioanalysis of Novel BiomarkersJean W. Lee, Wendell C. Smith, Gerald D. Nordblom, Ronald R. BowsherAbstract - Hi-Res PDF (526 KB) - PDF w/links (518 KB)
Chapter 7. Validation of Biomarkers as Surrogates for Clinical EndpointsMarc Buyse, Tony Vangeneugden, Luc Bijnens, Didier Renard, Tomasz Burzykowski, Helena Geys, Geert MolenberghsAbstract - Hi-Res PDF (423 KB) - PDF w/links (423 KB)
Chapter 8. Biomarkers for Pharmacokinetic/Pharmacodynamic Modeling and Clinical Trial SimulationsWayne A. ColburnAbstract - Hi-Res PDF (448 KB) - PDF w/links (452 KB)
Chapter 9. Pharmacogenomic BiomarkersRichard D. Hockett, Sandra C. KirkwoodAbstract - Hi-Res PDF (391 KB) - PDF w/links (399 KB)
Chapter 10. Quality Assurance and Regulatory ComplianceLinda F. Knoob, Angela Berns, Jacqueline HevyAbstract - Hi-Res PDF (362 KB) - PDF w/links (359 KB)
Chapter 11. Biomarker Strategies in Drug DevelopmentAbstract - Hi-Res PDF (318 KB) - PDF w/links (323 KB)
Chapter 12. Partnerships in Biomarker ResearchGregory J. DowningAbstract - Hi-Res PDF (397 KB) - PDF w/links (399 KB)
Chapter 13. Clinical OperationsAbstract - Hi-Res PDF (312 KB) - PDF w/links (313 KB)
