Design and Analysis of Bioavailability and Bioequivalence Studies

Design and Analysis of Bioavailability and Bioequivalence Studies

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Preeminent Experts Update a Well-Respected Book Taking 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 bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Third Edition * Four new chapters that present a thorough account of novel developments in the field * New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies * Reorganization of the material into five parts, making it easier to access related information together * Over 100 new references from the literature Like its bestselling predecessors, this edition covers all of the statistical problems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.
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Product details

  • Hardback | 760 pages
  • 162.56 x 238.76 x 38.1mm | 1,133.98g
  • Taylor & Francis Inc
  • Chapman & Hall/CRC
  • Boca Raton, FL, United States
  • English
  • Revised
  • 3rd Revised edition
  • 55 black & white illustrations, 221 black & white tables
  • 1584886684
  • 9781584886686

Review quote

... 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
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Table of contents

Preface Preliminaries Introduction History of Bioavailability Studies Formulation and Routes of Administration Pharmacokinetic Parameters Clinically Important Differences Assessment of Bioequivalence Decision Rules and Regulatory Aspects Statistical Considerations Aims and Structure of the Book Design of Bioavailability Studies Introduction The Study Objectives Basic Design Considerations The Parallel Design The Crossover Design The Balanced Incomplete Block Design The Selection of Design Statistical Inference for Effects from a Standard 2 x 2 Crossover Design Introduction The Carryover Effect The Direct Drug Effect The Period Effect The Analysis of Variance An Example Average Bioequivalence Statistical Methods for Average Bioequivalence Introduction The Confidence Interval Approach The Methods of Interval Hypothesis Testing Bayesian Methods Nonparametric Methods Discussion and Other Alternatives Power and Sample Size Determination Introduction Hypotheses and Type I and Type II Errors Power and Relative Efficiency Sample Size Determination Transformation and Analysis of Individual Subject Ratios Introduction Multiplicative (or Log-transformation) Model Bioequivalence Measures Maximum Likelihood Estimator Minimum Variance Unbiased Estimator Mean of Individual Subject Ratios Ration of Formulation Means Comparison of MLE, MVUE, MIR, and RM An Example Discussion The Assessment of Inter- and Intrasubject Variabilities Introduction Variability and Decision Making Point and Interval Estimates Test for Equality of Variabilities Equivalence in Variability of Bioavailability CV Assessment Discussion Assumptions of Outlier Detection for Average Bioequivalence Introduction Tests for Assumptions The Definition of Outlying Observations Detection of Outlying Subjects Detection of Outlying Observations Discussion Optimal Crossover Designs for Two Formulations for Average Bioequivalence Introduction Balaam's Design The Two-Sequence Dual Design Optimal Four-Period Designs Transformation and Individual Subject Ratios Sample Size for Higher-Order Crossover Designs Discussion Assessment of Average Bioequivalence for More Than Two Formulations Introduction Assessment of Average Bioavailability with More Than Two Formulations Analyses for Williams Designs Analysis for Balanced Incomplete Block Design Discussion Population/Individual Bioequivalence Population and Individual Bioequivalence Introduction Limitation of Average Bioequivalence Merits of Individual Bioequivalence and Desirable Bioequivalence Criteria Measures of Discrepancy Probability-Based Criteria Moment-Based Criteria Relations among Criteria Bioequivalence Limits Designs for Population and Individual Bioequivalence Discussion Statistical Procedures for Assessment of Population and Individual Bioequivalence Introduction Estimation Procedures Procedures for Moment-Based Criteria Procedures for Probability-Based Criteria Procedures for Evaluation of Population Bioequivalence Discussion In Vitro and Alternative Evaluation of Bioequivalence Assessment of Bioequivalence for Drugs with Negligible Plasma Levels Introduction Design and Clinical Endpoints Statistical Considerations Weighted Least Squares Methods Log-linear Models Generalized Estimating Equations (GEE) Analysis of Time to Onset of a Therapeutic Response Discussion In Vitro Bioequivalence Testing Background Regulatory Requirement Profile Analysis Nonprofile Analysis An Example Discussion In Vitro Dissolution Profiles Comparison Introduction Criteria for Assessment Similarity between Dissolution Profiles Estimation and Hypothesis Testing Based on f1 and f2 An Example Discussion Other Bioequivalence Studies Meta-analysis for Bioequivalence Review Introduction Meta-Analysis for Average Bioequivalence Alternative Method for Meta-Analysis Efficiency of Meta-Analysis Discussion Population Pharmacokinetics Introduction Compartment model Inter- and Intrasubject Variabilities Nonlinear Modeling NOMEN Discussion Evaluation of Dose Proportionality, Steady State, and Food Effects Introduction Drug Interaction Studies Assessment of Dose Proportionality Estimation of Steady State Evaluation of Food Effects Evaluation of Bioequivalence of Fixed-Combination Drug Products Discussion Review of FDA Guidances Introduction Guidance on Conjugated Estrogen Tablets Guidance on General Considerations Guidance on Statistical Procedures Guidance on Nasal Aerosols and Nasal Spray for Local Action Guidance on Scale-up and Postapproval Changes Discussion Some Related Issues and Future Challenges Introduction Assessment of Bioequivalence with Genomic Data Bridging Bioequivalence Studies Evaluation of Bioequivalence for Biological Products Medical Device Equivalence Post-approval Manufacturing Equivalence Discussion References Appendices Index
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About Shein-Chung Chow

Duke University School of Medicine, Durham, North Carolina, National Taiwan University, Taipei, Taiwan
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