Science and Quality Assurance, part 2: PK/QA

Abstract

For Quality Assurance to be a proactive partner in drug development we need to understand the scientific concepts that define and shape the pharmaceutical process. Drug development can be more easily understood by considering the basic scientific principles governing the numerous scientific disciplines that contribute to producing safe and effective drugs. This article describes the principles that apply to pharmacokinetics, and how these impact study design and data analysis. Copyright © 2005 John Wiley & Sons, Ltd.