Bioequivalence and Statistics in Clinical Pharmacology

Bioequivalence and Statistics in Clinical Pharmacology

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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the proposed methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, and dose-proportionality trials. Purposefully designed to be instantly applicable, the book provides examples of SAS code so that the analysis described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS. Each chapter includes a vignette based on co-author Scott Patterson's experience in the clinical pharmacology work place and all the data sets are taken from real trials. The authors delineate practical utility and objectives, provide real-world examples of the topic under discussion, and include statistical theory and applications. Technical theory, where extensive, is included in technical appendices at the end of the chapter. Each topic contains worked examples that illustrate the applications of the statistical techniques and their interpretation. The authors also develop statistical tools useful for other topics of clinical pharmacology - namely general safety testing, testing for proarrythmic potential, population pharmacokinetics, and more

Product details

  • Hardback | 400 pages
  • 160 x 233.7 x 25.4mm | 657.72g
  • Taylor & Francis Ltd
  • Chapman & Hall/CRC
  • Boca Raton, FL, United States
  • English
  • 56 black & white illustrations, 124 black & white tables
  • 1584885300
  • 9781584885306

Table of contents

DRUG DEVELOPMENT AND CLINICAL PHARMACOLOGY Aims of This Book Drug Development Clinical Pharmacology Statistics in Clinical Pharmacology Structure of the Book HISTORY AND REGULATION OF BIOEQUIVALENCE When and How BE Studies Are Performed Why Are BE Studies Performed? Deciding When Formulations Are Bioequivalent Potential Issues with TOST Bioequivalence Current International Regulation TESTING FOR AVERAGE BIOEQUIVALENCE Background Linear Model for 2 x 2 Data Applying the TOST Procedure Carry-over, Sequence, and Interaction Effects Checking Assumptions Made about the Linear Model Power and Sample Size for ABE in the 2 x 2 Design Example Where Test and Reference Are Not ABE Nonparametric Analysis Some Practical Issues BE STUDIES WITH MORE THAN TWO PERIODS Background Three-period Designs Within-subject Variability Robust Analyses for Three Period Designs Four-Period Designs Designs with More than Two Treatments Nonparametric Analyses of Tmax Technical Appendix: Efficiency Tables of Data DEALING WITH UNEXPECTED BE CHALLENGES Restricted Maximum Likelihood Modelling Failing BE and the DER Assessment Simulation Data-Based Simulation Carry-Over Optional Designs Determining Trial Size What Outliers are and How to Handle Their Data Bayesian BE Assessment Technical Appendix THE FUTURE AND RECENT PAST OF BE TESTING Brief History Individual and Population BE Scaled Average BE CLINICAL PHARMACOLOGY SAFETY STUDIES Background First-time-in-humans Sub-chronic Dosing Studies Food-Effect Assessment and DDIs Dose-Proportionality Technical Appendix QTC Background Modelling of QTc Data Interpreting the QTc Modelling Findings Design of a Thorough QTc Study in the Future Technical Appendix CLINICAL PHARMACOLOGY EFFICACY STUDIES Background Sub-chronic Dosing Phase IIa and the Proof of Concept Methodology Studies POPULATION PHARMACOKINETICS Population and Pharmacokinetics Absolute and Relative Bioavailability Age and Gender Pharmacokinetic Studies Ethnicity Liver Disease Kidney Disease Technical Appendix Epilogue Bibliography Indexshow more