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Pharmacometrics: an underused resource in Australian clinical research

To the Editor: Pharmacometrics is an emerging field in Australia, with use in a wide range of therapeutic areas including cardiovascular disease, critical patient care, diabetes and paediatrics.14 The results of pharmacometric analyses are often referred to in Therapeutic Goods Administration-approved product information; however, for many clinicians, pharmacometrics remains a mysterious area of research. Therefore, we seek to promote the discipline of pharmacometrics in clinical practice.

Pharmacometrics has its underpinnings in the principles of clinical pharmacology.5 It has been defined as “the science of developing and applying mathematical and statistical methods to: (a) characterize, understand, and predict a drug’s pharmacokinetic and pharmacodynamic behavior, (b) quantify uncertainty of information about that behavior, and (c) rationalize data-driven decision making in the drug development process and pharmacotherapy”.6

In the United States, pharmacometric analysis is widely applied in drug development and is used by the Food and Drug Administration to determine optimal dosing…