Bioequivalence and Statistics in Clinical Pharmacology

摘要

The book provides an introduction to statistical methods that are used in clinical pharmacology by walking a fine line between providing the reader with details on statistical concepts and methods, giving practical examples and discussing the relevant regulatory framework. As a consequence the reader must have a basic understanding of statistics and the drug development process to benefit from this book. Given this knowledge, however, the book provides a good introduction to common uses of statistics in early phases of the drug development process by using a good mix of technical detail, intuitive understanding and factual knowledge. The detailed familiarity and understanding of the subject by the authors shows throughout the book. This, on the one hand, leads to some very interesting, often overlooked, points being highlighted and discussed (e.g. efficiencies of different orderings in multiperiod designs: Chapter 4) whereas on the other they lose themselves in marginal points (e.g. the history of bioequivalence guidelines: Chapter 6) on occasion.