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Modern Clinical Trial Analysis
This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a diffe...
Clinical Trial Simulations
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.
Halcion
Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)â€"a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in t...
Ergonomics for All: Celebrating PPCOE's 20 years of Excellence
This book contains the selected papers presented at the 20th anniversary meeting of the Pan-Pacific Conference on Ergonomics organized by the Ergonomics Society of Taiwan. PPCOE 2010 is an international forum aimed to bring together scholars and practitioners from around the world to exchange and disseminate the latest developments in erg
Clinical Trial Biostatistics and Biopharmaceutical Applications
Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy...
Proceedings of the Conference on the Decline in Coronary Heart Disease Mortality
Abstract: Data on the decrease in coronary heart disease in the US are presented in a collection of papers. Change, and trends in the US are compared to international trends (based on mortality and hospital data). Possible causes for the decline, including pathophysiological bases, coronary care, and artery bypass grafts are covered. Finally, changes in risk factors are described: trends in smoking and hypertension; food consumption patterns; changes in blood cholesterol; relation of physical activity, and environmental and social variables. A summary strategy for quantifying and studying coronary heart disease change is included. (rkm).
Tzu Chi
This book captures well the history and spirit of Tzu Chi and its volunteers. It explains the passion and devotion that have made it the largest non-governmental organization in the Chinese-speaking world. Stan Shih Group Chairman Soft Capital Mark O'Neill's dispatches from Greater China over the span of many years have earned him a distinguished reputation as a gifted, insightful writer, versatile on a wide range of topics. A fluent Chinese speaker, he possesses that rare combination for a writer—of a keen nose for news as well as a heart for social responsibility. In Tzu Chi, he has chronicled the extraordinary story of a Chinese Buddhist nun whose selfless vision has built a global orga...
Statistics In the Pharmaceutical Industry
The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents c...
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
