Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition

"Praise for the previous editionThis monograph provides a thorough discussion of the design and analysis of bioavailability and bioequivalence studies. Besides describing the state of the art, the book also contains some material not easily found elsewhere." ---Statistical Software Newsletter "The explanations are excellent. All equations are stated explicitly and either discussed extensively or derived. Examples also are nicely done full-scale problems with good information and discussion of the results." ---Technometrics "Although the topics are presented in brief, they are explained in sufficient detail that they can be understoodan excellent resource[and] an excellent text." ---Journal of the National Cancer Institute "an outstanding book on the statistics of bioequivalence." ---Biopharmaceutical Report "unique in bringing together for the first time all of the available literature on the subject. In addition, it is well-referenced." ---Journal of the American Statistical Association "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 About the second edition. . . ..."a useful reference....also provides a historical perspective on the evolution of bioequivalence test methods in the context of regulatorypolicies 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 first edition of the book already reviewed and summarised remarkably extensively and well the related quantitative, and particularly statistical issues and procedures. The second edition of the book very substantially revises and expands the contents of the first editionThe book is well written and is quite comprehensive. It is useful particularly to statisticians involved in the design and assessment of bioequivalence studiesThe concepts are presented clearly, and the many numerical illustrations helpfully assist the reader to assimilate the material[T]his 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