Introduction to Dose Optimization in Drug Development. Bridging Preclinical and Clinical Development: Disease Progression Modeling in Translational Research. Bridging Preclinical and Clinical Development: Biomarker Validation and Qualification. Dose Selection for First-In-Human Study: A Regulatory Perspective. Novel Clinical Trial Designs in Clinical Pharmacology and Experimental Medicine. Biomarkers, Surrogate Endpoints, and Clinical Endpoints in the Development of Cardiovascular Drugs: A Regulatory Perspective. Pharmacokinetic and Pharmacodynamic Variability. Pharmacogenetics and Dose Response: Dose Individualization. Optimal Dose Finding in Drug Development: Approaches and Regulatory Perspectives. Optimal Dose Selection in Drug Development: Role of Population Pharmacokinetics in Phase 3. Dose Optimization Strategy for Strattera, A CYP2D6 Substrate. Pediatric Dose Optimization Using Pharmacokinetics/Pharmacodynamics