The advance of the pharmaceutical industry over the past decade is amazing, but the impact of this growth on statistics is somewhat puzzling. While the software has made analysis easier and more efficient, regulatory bodies now insist on deeper and more complicated analyses, and pharmacogenetic/genomic studies serve up a completely new set of challenges. For over two decades, Statistics in the Pharmaceutical Industry, 3rd Edition, (PDF) has been the definitive guide to arranging through the challenges in the industry, and this 3rd Edition continues that tradition.
Updated and extended 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 pharmaceutical companies and regulatory agencies who discuss everything from experimental design to post-marketing studies. This approach reflects on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters show the increasingly global nature of the industry as represented by authors from Europe and Japan, the increasing trend toward non-inferiority/equivalence testing, global harmonization of regulatory standards, adaptive design in clinical trials, and multiple comparison studies. The ebook also examines the latest considerations in anti-cancer studies.
Statistics in the Pharmaceutical Industry 3e clarifies the approval process by combining regulatory and industrial points of view, making it a must-have for anyone performing statistical analysis at any point in the drug approval process.
978-0824754693, 978-1420056457, 978-1315275888
Reviews
“…a comprehensive overview of many of the statistical issues that are met when doing research in the pharmaceutical industry and thus it is recommended to individuals who work or consult in this area of statistics. …a handy reference and is recommended for researchers/statisticians who work on problems in the pharmaceutical industry with some regularity.” ― Biometrics, March 2009
“The first edition of this ebook appeared in 1981 and the second in 1994 … have come chapters on testosterone replacement studies, stability studies, global harmonization, bridging studies, reference intervals and there are now three chapters on sequential and adaptive studies where formerly there was only one. … The ebook contains some fine and penetrating chapters. … and useful, summaries. …” ― Stephen Senn, Department of Statistics, University of Glasgow, UK, Statistics in Medicine, Vol. 23-25, 2004-2006
NOTE: The product only includes the ebook, Statistics in the Pharmaceutical Industry 3rd Edition in PDF. No access codes are included.
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