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-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