小児医薬品開発および臨床応用における生理学的薬物動態モデルの活用と現状

抄録

Pediatric pharmacokinetics and pediatric clinical pharmacology have attracted attention because of recent emphasis on drug development for the pediatric population in the US and Europe. Specifically, the US Food and Drug Administration (FDA) and Europe Medical Agency (EMA) have recommended using pharmacometric approaches in order to prepare a pediatric study plan (PSP) and a pediatric investigation plan (PIP), respectively. One of the approaches of interest is physiologically-based pharmacokinetic (PBPK) modeling and simulations, which can take into account age-dependent growth of body-size and developmental changes in organ functions. This paper is aimed at introducing the current status and ongoing discussions about applications of PBPK modeling for: pediatric drug development; understanding of pediatric PBPK modeling with pediatric physiology related drug disposition; and learning from case studies; and future perspectives.