Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective (Drugs and the Pharmaceutical Sciences, Vol 127) (Drugs and the Pharmaceutical Sciences)

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. This text details essential components of performing simulation for designing clinical trials via pharmacokinetic-pharmacodynamic modelling. It offers a range of applications for optimizing sampling strategies, selecting dosage and predicting drug efficacy and side-effects The decision processes of designing clinical trials have followed a largely ad hoc manner, driven by empiricism and embracing concepts such as "what was done previously" and "it has always been done this way." This book examines the background, construction, evaluation, and execution of simulation models for optimizing the design of clinical trials. -- book cover