Preface; Contents; Contributors; Biomarkers in Clinical Drug Development: Definitions and Disciplines; The Clinical Laboratory and Collection of Biomarker Data; Using Imaging Biomarkers to Demonstrate Efficacy in Clinical Trials: Trends and Challenges; Markers for Cardiac Repolarization and Risk Assessment; Development and Application of Interspecies Biomarkers in Nonclinical Safety Evaluations; Validation of Assays for the Bioanalysis of Novel Biomarkers: Practical Recommendations for Clinical Investigation of New Drug Entities; Validation of Biomarkers as Surrogates for Clinical Endpoints
Summary
Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development--utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds
