Chapter 8. Analysis of Human Pharmacokinetic Data

Scott Patterson^[]

^[] Scott Patterson is Director, Statistical Sciences, GlaxoSmithKline Pharmaceuticals, USA.

Brian Smith^[]

^[] Brian Smith is Principal Biostatistician II, Medical Sciences Biostatistics, Amgen, USA.

This chapter introduces pharmacokinetic terminology and also describes the collection, measurement, and statistical assessment of pharmacokinetic data obtained in Phase I and clinical pharmacology studies. It focuses on the following two topics that play a key role in pharmacokinetic analysis: testing for bioequivalence and assessing dose linearity. The chapter establishes a basic framework, and the examples demonstrate how to use restricted maximum likelihood models in the MIXED procedure to examine the most common pharmacokinetic data of practical interest.