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.

part 1|110 pages

Bioequivalence and Biopharmaceutical Development

chapter 1|12 pages

Drug Development and Clinical Pharmacology

chapter 2|16 pages

History and Regulation of Bioequivalence

chapter 3|32 pages

Testing for Average Bioequivalence

chapter 4|48 pages

BE Studies with More Than Two Periods

part 2|92 pages

Special Topics in Bioequivalence

chapter 5|28 pages

Dealing with Special BE Challenges

chapter 6|47 pages

Adaptive Bioequivalence Trials

chapter 7|14 pages

Scaled Average Bioequivalence Testing

part 3|101 pages

Clinical Pharmacology

chapter 8|39 pages

Clinical Pharmacology Safety Studies

chapter 9|12 pages


chapter 10|21 pages

Clinical Pharmacology Efficacy Studies

chapter 11|25 pages

Population Pharmacokinetics

part 4|35 pages

Vaccines and Epilogue

chapter 12|31 pages

Vaccine Trials

chapter 13|1 pages