Simulation for Designing Clinical Trials

Simulation for Designing Clinical Trials : A Pharmacokinetic-Pharmacodynamic Modeling Perspective

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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 practices. The book discusses how to 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, and the population relationship between dosing schedules and patient response.
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Product details

  • Hardback | 424 pages
  • 152 x 229 x 23.88mm | 703g
  • CRC Press Inc
  • Bosa Roca, United States
  • English
  • 0824708628
  • 9780824708627

Table of contents

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
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