Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p

chapter 1|16 pages

Introduction to Simulation for Design of Clinical Trials

ByHui C. Kimko, Stephen B. Duffull

chapter 2|14 pages

Input-Output Models

ByNicholas H. G. Holford

chapter 4|18 pages

Protocol Deviations and Execution Models

ByHelen Kastrissios, Pascal Girard

chapter 5|32 pages

Determination of Model Appropriateness

ByPaul J. Williams, Ene I. Ette

chapter 6|26 pages

Computational Considerations in Clinical Trial Simulations

ByJohn C. Pezzullo, Hui C. Kimko

chapter 7|22 pages

Analysis of Simulated Clinical Trials

ByEne I. Ette, Christopher J. Godfrey, Stephan Ogenstad, Paul J. Williams

chapter 9|28 pages

Choice of Best Design

ByJonathan P. R. Monteleone, Stephen B. Duffull

chapter 10|10 pages

Clinical Trial Simulation (CTS): A Regulatory Clinical Pharmacology Perspective

ByPeter I. D. Lee, Lawrence J. Lesko

chapter 11|16 pages

Academic Perspective: Modeling and Simulation as a Teaching

ByTool Nicholas H. G. Holford and Mats O. Karlsson

chapter 12|18 pages

Modeling and Simulation of Clinical Trials: An Industry Perspective

ByTimothy Goggin, Ronald Gieschke, Goonaseelan (Colin) Pillai, Ba¨rbel Fotteler, Paul Jordan, and Jean-Louis Steimer

chapter 15|24 pages

Use of Modeling and Simulation to Optimize Dose-Finding Strategies

ByJaap W. Mandema, Wenping Wang

chapter 16|14 pages

Model-Based Integration for Clinical Trial Simulation and Design: A Phase II Case Study for Naratriptan

ByIvan A. Nestorov, Gordon Graham, Stephen B. Duffull, Leon Aarons

chapter 17|26 pages

Prediction of Hemodynamic Responses in Hypertensive and Elderly Subjects from Healthy Volunteer Data: The Example of Intravenous Nicardipine

ByPatrice Francheteau, Henri Merdjan, Madeleine Guerret, Ste´phane Kirkesseli, Paolo Sassano, and Jean-Louis Steimer

chapter 19|22 pages

Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study

ByMarc R. Gastonguay, Ekaterina Gibiansky, Leonid Gibiansky, Jeffrey S. Barrett