BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY 2ED (PB 2020) Paperback

Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides a practical overview of the statistics commonly used in clinical pharmacology. It serves as an introductory resource for researchers, covering the essential methods needed to design, analyze, and interpret bioequivalence trials, and explaining the purpose and timing of these studies in drug development. Using real-world examples, the book illustrates statistical techniques employed in the field. Drawing from extensive experience in the pharmaceutical industry, the authors begin by outlining the role of statistics in drug development and regulatory applications. They then focus on the design and analysis of bioequivalence trials, including recent regulatory updates such as sample-size adaptation. The book also covers other clinical pharmacology topics, particularly those involving cross-over designs, such as safety studies in Phase I, dose-response trials, drug interactions, food-effect and combination studies, QTc and pharmacodynamic equivalence trials, proof-of-concept studies, dose-proportionality trials, and vaccine trials. This second edition incorporates new developments in the field, including chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials.