Simulation for Designing Clinical Trials

Introduction to Simulation for Design of Clinical Trials, H.C. Kimko and S.B. Duffull MODELS FOR SIMULATION Input-Output Models, N.H. G. Holford Defining Covariate Distribution Models for Clinical Trial Simulation, D.R. Mould Protocol Deviations and Execution Models, H. Kastrissios and P.l Girard Determination of Model Appropriateness, P.J. Williams and E. I. Ette COMPUTATION IN SIMULATION Computational Considerations in Clinical Trial Simulations, J.C. Pezzullo and H.C. Kimko ANALYSES OF THE SIMULATIONS Analysis of Simulated Clinical Trials, E.I. Ette, C.J. Godfrey, S. Ogenstad, and P.J. Williams Sensitivity Analysis of Pharmacokinetic and Pharmacodynamic Models in Clinical Trial Simulation and Design, I.A. Nestorov Choice of Best Design, J.P.R. Monteleone and S.B. Duffull PERSPECTIVES ON CLINICAL TRIAL SIMULATION Clinical Trial Simulation (CTS): A Regulatory Clinical Pharmacology Perspective, P.I.D. Lee and L.J. Lesko Academic Perspective: Modeling and Simulation as a Teaching Tool, N.H.G. Holford and M.O. Karlsson Modeling and Simulation of Clinical Trials: An Industry Perspective, T. Goggin, R. Gieschke, G. Pillai, B. Fotteler, P. Jordan, and J.-L. Steimer History-Informed Perspectives on the Modeling and Simulation of Therapeutic Drug Actions, J. Urquhart APPLICATIONS Evaluation of Random Sparse Sampling Designs for a Population Pharmacokinetic Study: Assessment of Power and Bias Using Simulation, M.M. Hutmacher and K.G. Kowalski Use of Modeling and Simulation to Optimize Dose-Finding Strategies, J.W. Mandema and W. Wang Model-Based Integration for Clinical Trial Simulation and Design: A Phase II Case Study for Naratriptan, I.A. Nestorov, G. Graham, S.B. Duffull, and L. Aarons Prediction of Hemodynamic Responses in Hypertensive and Elderly Subjects from Healthy Volunteer Data: The Example of Intravenous Nicardipine, P. Francheteau, H. Merdjan, M. Guerret, S. Kirkesseli, P. Sassano, and J.-L. Steimer Assessment of QTc Interval Prolongation in a Phase I Study Using Monte Carlo Simulation, P.L. Bonate Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study, M.R. Gastonguay, E. Gibiansky, L. Gibiansky, and J.S. Barrett Index