[Expanding therapeutic reference ranges using dose-related reference ranges]

Evidence-based therapeutic drug monitoring (TDM), which may be successfully employed to guide drug therapy in clinical routine, supplies all the information from laboratory determination of a drug concentration in a patient's blood specimen. This value is interpreted first of all in relation to a therapeutic reference range that must be established according to the same rules that are generally accepted for clinical studies aimed to license a new drug. The drug concentration may be furthermore interpreted in reference to a dose-related reference range. Thereby a signal is created to alert for individual abnormalities such as drug/drug interactions, gene polymorphisms that give rise to slow/rapid metabolizers, altered function of the excretion organs liver and kidneys by age and/or disease, compliance problems, a missing pharmacokinetic steady state, and even signal overlay in the laboratory analysis. We return all information available and clinical pharmacological comments to physicians who send specimens to our laboratory.