Evaluation of drugs in pediatrics using K-PD models: perspectives

Some pharmacodynamic (PD) models, called K-PD models, have been developed for the description of drug action kinetics in the absence of drug concentration measurements. Because blood samples for drug measurements are not needed, these models may be very useful in pediatric studies, by reducing their invasiveness. In addition, a number of PD measurements are also non-invasive and specific devices exist for measures in children. Therefore, the kinetics of drug action may be characterized with minimal invasiveness. A brief description of the key features of these models is given, and a number of examples of application are presented. K-PD models are expected to be most useful when the drug kinetics is simple (i.e. when the one-compartment model is a reasonable description), or when the response kinetics is slow compared with drug kinetics. K-PD models have already demonstrated their usefulness in animal and adult studies. They are very attractive for pediatric studies and they should facilitate the assessment of drug efficacy and safety.