Description: Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.
Review Quotes: "a detailed examination of the issues and practices of this area of applied statistics." -Journal of Mathematical Psychology "[W]e can recommend this book as a reference which can help different groups to understand current methodologies and applications of statistics in drug industry. It provides a nice and clearly structured overview on each topic and may lower potential barriers for further studying each area." -ISCB News, December 2003