PK/PD modeling in the perinatal period

抄録

Perinatal period represents a continuous and dynamically changing state of growth and development. Marked differences in the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of many drugs are reported between newborns and adults due to the developmental changes in physiological parameters during perinatal period. The lack of clinical trial data directly results in the variation and uncertainty of drug therapy in clinical practice. There has been a growing interest in exploring innovative methodology to optimize drug therapy in this vulnerable population. In this context, PK-PD modeling presents a promising and valuable approach. PK-PD modeling is the science of quantitative pharmacology. In application to pediatrics, it involves primarily developmental PK and PD modeling and simulation, which can combine information from many diverse sources as drug characteristics, developmental clinical pharmacology, physiological changes during childhood, pediatric disease and statistics. This presentation will use cases studies to demonstrate how to apply PK-PD modeling in optimization of clinical trial design and personalized drug therapy in perinatal period.