Simulation for Designing Clinical Trials discusses:

• selecting clinical trial designs according to their probability for success
• techniques to define distributions of virtual subjects’ characteristics
• methods to determine the sensitivity of the trial design
• the population relationship between dosing schedules and patient response

Contents

1. Introduction to Simulation for Design of Clinical Trials

Models for Simulation

2. Input-Output Models
3. Defining Covariate Distribution Models for Clinical Trial Simulation
4. Protocol Deviations and Execution Models
5. Determination of Model Appropriateness

Computation in Simulation

6. Computational Considerations in Clinical Trial Simulations

Analyses of the Simulations

7. Analysis of Simulated Clinical Trials
8. Sensitivity Analysis of Pharmacokinetic and Pharmacodynamic Models in Clinical Trial Simulation and Design
9. Choice of Best Design

Perspectives on Clinical Trial Simulation

10. Clinical Trial Simulation (CTS): A Regulatory Clinical Pharmacology Perspective
11. Academic Perspective: Modeling and Simulation as a Teaching Tool
12. Modeling and Simulation of Clinical Trials: An Industry Perspective
13. History-Informed Perspectives on the Modeling and Simulation of Therapeutic Drug Actions

Applications

14. Evaluation of Random Sparse Sampling Designs for a Population Pharmacokinetic Study: Assessment of Power and Bias Using Simulation
15. Use of Modeling and Simulation to Optimize Dose-Finding Strategies
16. Model-Based Integration for Clinical Trial Simulation and Design: A Phase II Case Study for Naratriptan
17. Prediction of Hemodynamic Responses in Hypertensive and Elderly Subjects from Healthy Volunteer Data: The Example of Intravenous Nicardipine
18. Assessment of QTc Interval Prolongation in a Phase I Study Using Monte Carlo Simulation
19. Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study

Index

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