Drug doses are often titrated upon their clinical effects (e.g., blood pressure). Unfortunately, for many drugs there is no direct, clinical read-out to estimate dose adequateness. Alternatively, drug dosing is based on the maximum tolerated dose approach or therapeutic drug monitoring. However, the concentration-response curves may be flattened or bell-shaped as suggested for some 'biologicals'. Together, these aspects raise the question why drug dosing is not individualized by pharmacodynamic monitoring. Evaluating the effects of drugs at their pharmacological target or meaningful biomarkers might indicate nonresponders, objectively quantify the maximum molecular effect and thus restrict overdose and underdosing. This review outlines the theory and biological or technical prerequisites for biomarker-based pharmacodynamic monitoring, and highlights selected examples from different fields of clinical medicine.
Keywords: biomarkers; drug dosing; drug individualization; pharmacodynamic monitoring; therapeutic drug monitoring.