Therapeutic drug monitoring as a component of personalized medicine: applications in pediatric drug development.

Therapeutic drug monitoring (TDM) is foundational to the concept of personalized medicine. TDM transformed drug therapy by affording the ability to characterize sources of variability in drug disposition and response to individualize drug dosing. Initially, TDM formed the key conceptual basis for personalized medicine, which has evolved to include pharmacogenomic and other biomarker-driven strategies for patient segmentation. Currently, TDM is an attractive option for personalized medicine and, under the right conditions, can facilitate drug development.