This text outlines the applications of statistics for each stage of pharmaceutical development. It ensures the valid design, analysis and assessment of drug products under investigation and discusses the testing of population/individual bioequivalence and in vitro bioequivalence.
Chow (Temple U.) and Shao (U. of Wisconsin-Madison) explain the application of statistics used during the various stages of pharmaceutical research and development to demonstrate quality, safety, and efficacy in research and development. Among the contexts they consider are assa…
