Encyclopedia of biopharmaceutical statistics [electronic resource] /
edited by Shein-Chung Chow.
3rd ed., rev. and expanded.
New York : Informa Healthcare, 2010.
xvii, 2 v. (1474 p.) : ill.
143982245X, 9781439822456
More Details
New York : Informa Healthcare, 2010.
Licensed for access by U. of T. users.
catalogue key
Includes bibliographical references and index.
A Look Inside
Review Quotes
Praise for Previous Editions: "I was delighted by the information and insight that was available … The authors demonstrate their expertise and knowledge in well-written material that covers each of the topics fully. …These authors are to be congratulated for a job well done." -Ralph Bucher, professor of biostatistics, University of Cincinnati, and fellow of ASA and American College of Epidemiology "… an essential desktop reference …" -Technometrics
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Main Description
Available in both print and online versions, this is the definitive statistics reference for biopharmaceutical research and manufacturing, presenting current standards and best practices for the laboratory, manufacturing, and statistical design, investigation, and analysis. Thoroughly exploring emerging technologies, concepts, and trends, this second edition incorporates 69 new sections on subjects ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials, and medical devices. It reviews recent amendments to regulatory requirements and presents newer statistical methods applicable to the drug development, review, and approval processes.
Main Description
In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine

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