chapter 1 Introduction to Simulation for Design of Clinical Trials / chapter 2 Input-Output Models / chapter 3 Defining Covariate Distribution Models for Clinical Trial Simulation / chapter 4 Protocol Deviations and Execution Models / chapter 5 Determination of Model Appropriateness / chapter 6 Computational Considerations in Clinical Trial Simulations / chapter 7 Analysis of Simulated Clinical Trials / chapter 8 Sensitivity Analysis of Pharmacokinetic and Pharmacodynamic Models in Clinical Trial Simulation and Design -- chapter 9 Choice of Best Design / chapter 10 Clinical Trial Simulation (CTS) -- chapter 11 Academic Perspective: Modelling and Simulation as a Teaching Tool -- chapter 12 Modeling and Simulation of Clinical Trials: An Industry Perspective -- chapter 13 History-Informed Perspectives on the Modeling and Simulation of Therapeutic Drug Actions -- chapter 14 Evaluation of Random Sparse Sampling Designs for a Population Pharmacokinetic Study: Assessment of Power and Bias Using Simulation -- chapter 15 Use of Modeling and Simulation to Optimize Dose-Finding Strategies / chapter 16 Model-Based Integration for Clinical Trial Simulation and Desing: A Phase II Case Study for Naratriptan -- chapter 17 Prediction of Hemodynamic Responsed in Hypertensive and Elderly Subjects from Healthy Volunteer Data -- chapter 18 Assessment of QTc Interval Profilongation in a Phase I Study Using Monte Carlo Simulation -- chapter 19 Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study.