Search results for ""Author Shein-Chung Chow""

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and an

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Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients. Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research. Documents Alternative Research Approaches for Faster and More Accurate Data Judgment CallsElaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts. This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

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Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

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