Design and Analysis of Bioavailability and Bioequivalence Studies PDF

Rating: (1 reviews) Author: Shein-Chung Chow ISBN : 9780824786823 New from $16.80 Format: PDF

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This practical reference/text, written at a basic mathematical and statistical level, presents important statistical concepts for assessing bioequivalence through "real" examples and provides a thorough, unified discussion of the design and analysis of bioavailability and bioequivalence studies. Furnishing a comprehensive overview of the field and comparing average bioavailability methods, "Design and Analysis of Bioavailability and Bioequivalence Studies": supplies a simple formula for sample size determination; explains techniques for checking model assumptions and detecting outlying data; compares the additive model and the multiplicative model; demonstrates statistical methods of assessing more than two formulations; and delineates bioequivalence assessment with negligible plasma levels. As a fundamental text in the classroom or for self-education, "Design and Analysis of Bioavailability and Bioequivalence Studies": contains various study designs based on different needs and objectives; offers over 400 display equations but requires no mathematics beyond simple algebra; and incorporates time-saving SAS programmes and an appendix of statistical tables. "Design and Analysis of Bioavailability and Bioequivalence Studies" is intended for biostatisticians; applied statisticians; biometricians; pharmacologists; clinical, industrial and research pharmacists; and drug regulatory personnel; as well as an for all upper-level undergraduate and graduate courses in bioavailability and bioequivalence, pharmacokinetics, pharmaceutics and biostatistics.

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• Product Details
• Table of Contents
• Reviews

• Series: Statistics: a Series of Textbooks and Monogrphs
• Hardcover: 432 pages
• Publisher: Marcel Dekker Inc (June 1992)
• Language: English
• ISBN-10: 0824786823
• ISBN-13: 978-0824786823
• Product Dimensions: 9.5 x 6.5 x 1 inches
• Shipping Weight: 1.6 pounds

Design and Analysis of Bioavailability and Bioequivalence Studies PDF

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 particularly interested in the bootstrap confidence interval approaches to individual bioequivalence and for a time the FDA 1997 Guidance recommended the bootstrap approach. But in recent 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 disappointed that there was no discussion of an adaptive design for bioequivalence. I did such a two-stage design while working 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. To every method there are numerical examples given with real data. Methods for individual and population bioequivalence are complicated and the authors cover all the complications in detail.