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Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition (Chapman & Hall/Crc Biostatistics Series) | 
 enlarge | Authors: Shein-chung Chow, Jen-pei Liu
Publisher: Chapman & Hall/CRC
Category: Book
List Price: $99.95
Buy New: $84.99
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New (16) Used (3) from $84.99
Rating:  1 reviews
Sales Rank: 656046
Media: Hardcover
Edition: 3
Number Of Items: 1
Pages: 760
Shipping Weight (lbs): 2.5
Dimensions (in): 9.4 x 6.4 x 1.5
ISBN: 1584886684
Dewey Decimal Number: 615.7
EAN: 9781584886686
ASIN: 1584886684
Publication Date: October 15, 2008
Availability: Usually ships in 1-2 business days
Shipping: International shipping available
Condition: Brand new item. Over 4 million customers served. Order now. Selling online since 1995. Few left in stock - order soon. Code: C20081228095740C
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Product Description
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 methodology. New to the Third Edition • Four new chapters that present a thorough account of novel developments in the field • New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies • Reorganization of the material into five parts, making it easier to access related information together • Over 100 new references from the literature Like its bestselling predecessors, this edition covers all of the statistical problems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.
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| Customer Reviews:
could be the bible on bioequivalence January 7, 2009
It has been over 9 years since the second edition of this book came out. In that time there has been a lot of new research and developments in regulatory guidelines regarding individual and population bioequivalence. I was particualrly interested in the bootstrap confidence interval approaches to individual bioequivalence and for a time the FDA 1997 Guidance recommended the bootstrap approach. But in recentr years the old standby, average bioequivalence is back in favor. All these events are chronicled in this book. The book is greatly expanded and contains 4 new chapters and around 100 new references. Most topics are covered in great detail and the text appears to be highly detailed.
One thing that did bother me though was the large number of references to the 1993 paper by Schall and Luus in Statistics in Medicine. In the paper they provide a bootstrap approach that Shao and Pigeot proved was not consistent. It surprises me that Pigeot's survey articles in the DIJ and the joint work of Shao and Pigeot are not referenced and I did not see any disclaimers about the Schall and Luus procedure. I was also surprised that there was no discussion of an adaptive design for bioequivalence. I did such a two-stage design while worrking at Auxilium. It involved sample size reestimation at an interim time point using an AB/BA crossover design.
Nevertheless this book is a fantastic reference for bioavailability and bioequivalence and is definitely worth having.
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