Pharmacometrics can be defined as that branch of science concerned with mathematical models of biology, pharmacology, disease, and physiology used to describe and quantify interactions between xenobiotics and patients (human and non-human), including beneficial effects and adverse effects. It is normally applied to quantify drug, disease and trial information to aid efficient drug development, regulatory decisions and rational drug treatment in patients.
Contents
Pharmacometrics uses models based on pharmacology, physiology and disease for quantitative analysis of interactions between drugs and patients. This involves Systems pharmacology, pharmacokinetics, pharmacodynamics and disease progression with a focus on populations and variability.
Drug models describe the relationship between exposure (or pharmacokinetics), response (or pharmacodynamics) for both desired and undesired effects. See also dose-response.
Disease models describe the time course of disease and placebo effects. Disease and drug models are used to understand the relationship between treatment, biomarker changes and clinical outcomes.
Trial models describe variations from the nominal trial protocol due to things such as patient dropout and lack of adherence to the dosing regimen.
Mould and Upton provide an overview of basic concepts in population modeling, simulation, and model-based drug development.
A major focus of pharmacometrics is to understand variability in drug response. Variability may be predictable (e.g. due to differences in body weight or kidney function) or apparently unpredictable (a reflection of current lack of knowledge).
Organizations
Historically, pharmacometrics has been represented in related clinical pharmacology and statistics organizations. A number of smaller local organizations in Europe, United States, and New Zealand/Australia held local meetings. In the early 90's, The PAGE meeting was organized and has been held yearly since then, although no official organization was present. Ette and Williams have provided a historical context from which the evolution of pharmacometrics can be appreciated.
In 2011, the American Society of Pharmacometrics (ASoP) was founded from a number of local American groups, and over 600 members worldwide joined ASoP within 6 months. In 2012, ASoP evolved to the International Society of Pharmacometrics (ISoP) to reflect the increasing number of international members. ISoP’s growth continues and the Society currently represents over 1000 members from almost 30 countries around the world. Regional groups include PAGE in Europe and PAGANZ in Australia and New Zealand.
Pharmacometricians typically come from disciplines such as Clinical Pharmacology, Statistics, Medicine,or Engineering. The first professor of pharmacometrics was Mats Karlsson, Uppsala University.