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…
Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.
Praised by practitioners, students and instructors for its engaging approach to teaching a very complex subject, Demystifying Opioid Conversion Calculations: A Guide for Effective Dosing, has long been the go-to guide for learning how to calculate opioid conversions. Now in its …