Базовая цена: 2 550 ₽
Издательство: Chapman & Hall/CRC
Год издания: 2016
ISBN: 978-0-8247-5469-3
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 pharmacogenomic genome 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 chapters written by experts from both regulatory agencies and pharmaceutical companies that discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry, the increasing trend toward noninferiority/equivalence testing, adaptive design in clinical trials, global harmonization, regulatory standards, bridging strategies in global drug development, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Still the best, most integrated reference in the field, this Third Edition: Provides updated material in every chapter to reflect the massive growth and change over the past decade. Includes new chapters on topics such as testosterone replacement therapy trials and active-controlled equivalence trials. Addresses the most current and emerging statistical issues involved in HIV/AIDS research and anti-cancer trials. Presents a global view of pharmaceutical development in pertinent chapters by authors from ICH major global regions. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.
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