Pharmacokinetics is the study of the absorption, distribution, metabolism, and excretion of drugs. Simply put, pharmacokinetics is what the body does to the drug, which is opposed to pharmacodynamics, which is what the drug does to the body. This review will introduce pharmacokinetics as a science showing how biochemistry, biology, pharmacology, and physiology interact to explain how a drug ‘works’. Pharmacokinetics is becoming increasingly quantitative with population pharmacokinetics–pharmacodynamics, which uses nonlinear mixed effects model methodology, becoming more and more commonplace and acting as the core to model-based drug development. This review will show how statistics is becoming increasingly more important in pharmacokinetic analysis and provide an introduction to statistical analysis of pharmacokinetic data. WIREs Comp Stat 2011 3 332–342 DOI: 10.1002/wics.153

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