chapter 1 Biomarkers in Clinical Drug Development: Definitions and Disciplines -- chapter 2 The Clinical Laboratory and Collection of Biomarker Data -- chapter 3 Using Imaging Biomarkers to Demonstrate Efficacy in Clinical Trials: Trends and Challenges -- chapter 4 Markers for Cardiac Repolarization and Risk Assessment -- chapter 5 Development and Application of Interspecies Biomarkers in Nonclinical Safety Evaluations -- chapter 6 Validation of Assays for the Bioanalysis of Novel Biomarkers: Practical Recommendations for Clinical Investigation of New Drug Entities -- chapter 7 Validation of Biomarkers as Surrogates for Clinical Endpoints -- chapter 8 Biomarkers for Pharmacokinetic/Pharmacodynamic Modeling and Clinical Trial Simulations -- chapter 9 Pharmacogenomic Biomarkers -- chapter 10 Quality Assurance and Regulatory Compliance -- chapter 11 Biomarker Strategies in Drug Development: Striking a Balance Between Opportunities and Liabilities -- chapter 12 Partnerships in Biomarker Research -- chapter 13 Clinical Operations: Business Principles for Biomarker Applications.