Design and Analysis of Bioavailability and Bioequivalence Studies

by Shein-Chung Chow, Jen-pei Liu

Overview

Preeminent Experts Update a Well-Respected BookTaking 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 bioequiva

Product Details

ISBN-13:	9781040067475
Publisher:	CRC Press
Publication date:	10/15/2008
Series:	Chapman & Hall/CRC Biostatistics Series
Sold by:	Barnes & Noble
Format:	eBook
Pages:	760
File size:	5 MB

About the Author

Shein-Chung Chow, Jen-pei Liu

Table of Contents

Preface. Preliminaries. Average Bioequivalence. Population and Individual Bioequivalence. In Vitro and Alternative Evaluation of Bioequivalence. Other Bioequivalence Studies. References. Appendices. Index.

Editorial Reviews

"The first edition of this book...was favourable reviewed in the pages of this journal. The second edition brings with it some 170 further pages....new material includes sample size determination for higher order cross|over designs, meta|analysis for bioequivalence, and introduction to population and individual bioequivalence and some regulatory comments. "The book is a thorough expose of a subject about which the authors have considerable expert knowledge. Its strengths are its encyclopaedic coverage of the subject."

Biometrics

...a useful reference....also provides a historical perspective on the evolution of bioequivalence test methods in the context of regulatory policies and public debates on these issues. Detailed description of current statistical concepts, methodology, and underlying assumptions are provided and exemplified. The emphasis of this volume is on statistical concepts and methodology (as it should be).

Pharmaceutical Research 2000

...extremely well-written and well-printed....a ‘must read' book to the students, practitioners and researchers of bioavailability and bioequivalence studies.

Statistical Methods in Medical Research

...a useful reference also provides a historical perspective on the evolution of bioequivalence test methods in the context of regulatory policies and public debates on these issues. Detailed description of current statistical concepts, methodology, and underlying assumptions are provided and exemplified. The emphasis of this volume is on statistical concepts and methodology (as it should be).

Pharmaceutica Research

...The list of authors includes more than 100 of the most prominent specialists from all over the world highly informative.

New England Journal of Medicine

...well written and meets its objectives.

Statistics in Medicine

A reference for researchers and scientists in academia, industry, and government and a textbook for a graduate or undergraduate course. Chow (Temple U., Philadelphia) and Liu (National Health Research Institutes, Taipei) update their 1992 edition to accommodate developments in such areas as the search for alternative bioequivalence measures, the methods for highly variable drugs, the correlations between dissolution testing and bioequivalence testing, and the concept of individual bioequivalence for drug switchability. They focus on concepts rather than technical details, and take a practical perspective at a basic mathematical and statistical level. The techniques are used in pharmacokinetics, clinical pharmacology, and biostatistics. Annotation c. Book News, Inc., Portland, OR (booknews.com)

Booknews

… the improvement in the table of contents … makes it easier to navigate around the book. The new addition has added many new and extra chapters, which does a more comprehensive job of covering the subject of bioavailability and bioequivalence. … The SAS examples are better laid out in the new edition and these provide good resources in analyzing these studies. The first and second editions of this book have been invaluable for me … and I think it would be a good addition to anybody’s shelf. I would encourage anybody working in the industry to ensure there is a copy in their company. The mathematics in the book is not so complex as to make it unreadable for a nonmathematical person. It offers good insight into the workings of the regulatory guidelines and gives good practical advice in dealing with difficult situations.
—Alun Bedding, Pharmaceutical Statistics, 2010

…the book provides an encyclopedic coverage of all these issues and more. … [The first] two parts could lead to a good course on bioequivalence and its proxy, namely, bioavailability. …
—International Statistical Review (2009), 77, 2

The text is well written and rich in all statistical methods … In summary, the book provides an important reference covering nearly all of the most relevant literature. Hence, it is a very valuable reference for anyone interested in the statistical aspects of bioequivalence.
—Journal of Biopharmaceutical Statistics, 2009

Praise for the Second Edition
…The second edition brings with it some 170 further pages … new material includes sample size determination for higher order cross-over designs, meta-analysis for bioequivalence, and introduction to population and individual bioequivalence and some regulatory comments. The book is a thorough expose of a subject about which the authors have considerable expert knowledge. Its strengths are its encyclopedic coverage of the subject.
—Biometrics

…a useful reference … also provides a historical perspective on the evolution of bioequivalence test methods in the context of regulatory policies and public debates on these issues. Detailed description of current statistical concepts, methodology, and underlying assumptions are provided and exemplified. The emphasis of this volume is on statistical concepts and methodology (as it should be).
—Pharmaceutical Research, 2000

… The second edition of the book very substantially revises and expands the contents of the first edition … The book is well written and is quite comprehensive. It is useful particularly to statisticians involved in the design and assessment of bioequivalence studies …The concepts are presented clearly, and the many numerical illustrations helpfully assist the reader to assimilate the material … this is a valuable review of principles and procedures for the statistical assessment of bioequivalence studies. It can be recommended particularly for statisticians involved in these kinds of clinical trials. Non-statisticians interested in the quantitative aspects of these investigations could also benefit from its perusal.
—ISCB News, June 2004

From the Publisher