This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
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...
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications...
When Professor Laura Ranum received an offer from the University of Florida to found and direct a new Center for NeuroGenetics, her husband and the author of this book, Bert Ranum, concluded he...
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of...
Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation,...
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