Design and Analysis of Bioavailability and Bioequivalence Studies
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Design and Analysis of Bioavailability and Bioequivalence Studies: (Chapman & Hall/CRC Biostatistics Series)

Design and Analysis of Bioavailability and Bioequivalence Studies: (Chapman & Hall/CRC Biostatistics Series)


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About the Book

"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."

Table of Contents:
Designs of bioavailability studies; statistical inferences for effects from a standard 2x2 crossover design; statistical methods for average bioavailability; power and sample size determination; transformation and analysis of individual subject ratios; the assessment of inter- and intrasubject variabilities; assumptions and outliers detection; optimal crossover designs for two formulations; assessment of bioequivalence for more than two formulations; assessment of bioequivalence for drugs with negligible plasma levels; some related problems in bioavailability studies; metanalysis for bioequivalence - review; population and individual bioequivalence; review of FDA guidances. Appendices: statistical tables; SAS programs.

Review :
"Praise for the previous edition…This 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 understood…an 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 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 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 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…[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


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Product Details
  • ISBN-13: 9781420002027
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: CRC Press Inc
  • Language: English
  • No of Pages: 600
  • ISBN-10: 1420002023
  • Publisher Date: 24 Nov 1999
  • Binding: Digital (delivered electronically)
  • No of Pages: 600
  • Series Title: Chapman & Hall/CRC Biostatistics Series


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