Ette E.I., Williams P.J. (Eds.) Pharmacometrics. The Science of Quantitative Pharmacology

Hoboken: John Wiley & Sons. - 2007. -1225 p. The subspecialty of population pharmacokinetics was introduced into clinical pharmacology / pharmacy in the late 1970s as a method for analyzing observational data collected during patient drug therapy in order to estimate patient-based pharmacokinetic parameters. It later became the basis for dosage individualization and rational pharmacotherapy. The population pharmacokinetics method (i.e., the population approach) was later extended to the characterization of the relationship between pharmacokinetics and pharmacodynamics, and into the discipline of pharmacometrics. Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. Vast amounts of data are generated during clinical trials and patient care, and it is the responsibility of the pharmacometrician to extract the knowledge embedded in the data for rational drug development and harmacotherapy. He/she is also responsible for providing that knowledge for decision making in patient care and the drug development process. In the writing of this text, the reader's knowledge of pharmacokinetics, pharmacodynamics, and statistics is assumed. If not, the reader is referred to Applied Pharmacokinetics by Shargel and Yu, Pharmacokinetics by Gibaldi and Perrier, Pharmacokinetics and Pharmacodynamics by Gabrielson and Weiner, and statistics from standard textbooks. This book is written for the graduate students or postdoctoral fellows who want to specialize in pharmacometrics; and for pharmaceutical scientists, clinical harmacologists/ pharmacists, and statisticians in academia, regulatory bodies, and the pharmaceutical industry who are in pharmacometrics or are interested in developing their skill set in the subject.Pharmacometrics: impacting drug development and pharmacotherapy
General principles
Population pharmacokinetic basis of pharmacometrics
Pharmacokinetics / pharmacodynamics relationship: biomarkers and pharmacogenomics, pk/pd models for continuous data, and pk/pd models for outcomes data
Clinical trial designs
Pharmacometric service and communication