Clinical Trials - Pharmaceutical Science

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-u..

Covering even more adaptive designs, this second edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. It includes 12 new chapters, more analytical methods, 20 new SAS macros and R functions, and enhanced end-of-chapter problems that give re..

Written by leading pioneers of Bayesian clinical trial designs, this book explores the growing role of Bayesian thinking in clinical trial analysis. Covering Phase I, II, and III clinical trials, it establishes the basic principles before extending them to specific phases and endpoints. The authors ..

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinica..

The main goal of this book is to define a unified framework for clinical trial optimization based on a comprehensive quantitative evaluation of relevant clinical scenarios (using the clinical scenario evaluation approach) and introduce best practices for simulationbased optimization. The book will b..

Focusing on the day-to-day needs of a clinical trials manager, this book explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations. After building a foundation of basic principles, the authors lead ..

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to a number of factors that should be, at least partially, predictable from preclinical testing. Computer Techniques in Preclinical and Clinical Drug Development asks the question, "How can we use computat..

This volume helps medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables researchers, even those with no background in statistics, determine sample size and write statisti..

The third edition presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. It also contains numerous figures and e..

The third edition presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. It also contains numerous figures and e..

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their pract..

Helping you become a skillful "simulator," this book provides broad coverage of the drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods for carrying out computer simulations efficiently, covers both descri..