학술논문

Physiologically Based Pharmacokinetics Modeling in the Neonatal Population—Current Advances, Challenges, and Opportunities.
Document Type
Article
Source
Pharmaceutics. Nov2023, Vol. 15 Issue 11, p2579. 21p.
Subject
*PHARMACOKINETICS
*KNOWLEDGE gap theory
*HUMAN physiology
*PREMATURE infants
*NEWBORN infants
*ONTOGENY
*PREDICTION models
Language
ISSN
1999-4923
Abstract
Physiologically based pharmacokinetic (PBPK) modeling is an approach to predicting drug pharmacokinetics, using knowledge of the human physiology involved and drug physiochemical properties. This approach is useful when predicting drug pharmacokinetics in under-studied populations, such as pediatrics. PBPK modeling is a particularly important tool for dose optimization for the neonatal population, given that clinical trials rarely include this patient population. However, important knowledge gaps exist for neonates, resulting in uncertainty with the model predictions. This review aims to outline the sources of variability that should be considered with developing a neonatal PBPK model, the data that are currently available for the neonatal ontogeny, and lastly to highlight the data gaps where further research would be needed. [ABSTRACT FROM AUTHOR]