"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 ..."
"Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical method ..."
"As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues ..."
Design and Analysis of Clinical Trials(2nd Edition) Concepts and Methodologies (Wiley Series in Probability and Statistics) by Shein-Chung Chow, Jen-PeiLiu Hardcover, 752 Pages, Published 2003 by Wiley-Interscience ISBN-13: 978-0-471-24985-6, ISBN: 0-471-24985-8
"Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." -Statistical Methods in Medicine A complete and balanced presentation now revised, updated ..."
""Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples.""
""Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters.""
"In: Peace K, ed. Biopharmaceutical Statistics for Drug Development. New York:
Marcel Dekker, 1988, pp 1–20. Jonckheere AR. A distribution free k-sample test
against ordered alternatives. Biometrika 41:133-145, 1954. Keene JH, Sansone
EG. Airborne transfer of contaminants in ventilated spaces. Lab Anim Sci 34:453-
457, 1984. Krewski D, Bickis M. Statistical issues in toxicological research. In:
Krewski D, Franklin C, eds. Statistics ..."
"Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical practice but may not have been adequately evaluated. This situation is an important barrier f ..."
"Dissolution. Profiles. Comparison. 15.1. Introduction. In vivo bioequivalence
studies are surrogate trials for assessing equivalence between a test and a
reference formulations based on the rate and extent of drug absorption in
humans without actually performing clinical trials to establish similar
effectiveness and safety. The Fundamental Bioequivalence Assumption implies
that bioequivalent formulations are therapeutically equival ..."
Design and Analysis of Clinical Trials(1st Edition) Concept and Methodologies (Wiley Series in Probability and Statistics) by Shein-Chung Chow, Jen-PeiLiu Hardcover, 672 Pages, Published 1998 by Wiley-Interscience ISBN-13: 978-0-471-13404-6, ISBN: 0-471-13404-X
"A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, ..."
"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 PracticesThe 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 provid ..."
"Some content that appears in print may not be available in electronic formats. For
more informationaboutWiley products, visitourweb siteat www.wiley.com. Library
of Congress CataloginginPublication Data: Chow, SheinChung, 1955 Design
and analysis of clinicaltrials: concepts and methodologies/ SheinChung Chow,
JenPei Liu.– 3rd ed. p.cm. Includes index. ISBN 9780470887653 (cloth) 1.
Clinical trials–Methodology. 2. Clinical trials–Sta ..."
"This monumental reference on all facets of clinical trials provides comprehensive coverage and emphasis on clearly stated and defined concepts, methodologies, and applications. With more than 450entries, from 350 of the world's leading experts in the field in academic and corporate settings, Encyclopedia of Clinical Trials is a world-class and one-of-a-kind compendia of basic concepts, methodologies, and applications in clinical trials. ..."
"Preface Many statistical and/or scientific issues in the area of bioavailability and
bioequivalence have attracted considerable attention from pharmaceutical
scientists and researchers from academia, the regulatory agencies, and the ...
include the search for alternative bioequivalence measures, the methods for
highly variable drugs, the correlation between in vitro dissolution testing and in
vivo bioequivalence testing, and the co ..."
""Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world ..."