Publisher: Chapman and Hall/CRC
Year of Publication: 2016
Author(s) : Scott D. Patterson, Byron Jones
Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and 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 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, including recent regulatory changes in design and analysis and in particular sample-size adaptation, 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, proof-of-concept trials, dose-proportionality trials, and vaccines trials.
This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials.
Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.
• A wide range of examples, derived from drug development and regulatory applications, with data sets and analysis code available on the Internet.
• Applications of statistics in clinical pharmacology drug development with an emphasis on scientific and regulatory applications.
• Discussion of manufacturing, safety, pharmacokinetic, immunology, and efficacy assessment in biopharmaceutical development and clinical pharmacology, and where and how statistics fit in.
• Presents the real-world use of statistical analysis and design of bioequivalence and clinical pharmacology studies for use in medical, scientific, and regulatory decision making and drug and vaccine labelling.