Dinh Jean, Johnson Trevor N, Grimstein Manuela, Lewis Tamorah
Certara UK Limited, Sheffield S1 2BJ, UK.
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA.
Pharmaceutics. 2023 Nov 3;15(11):2579. doi: 10.3390/pharmaceutics15112579.
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.
基于生理的药代动力学（PBPK）建模是一种利用人体生理学知识和药物理化性质来预测药物药代动力学的方法。在预测研究不足的人群（如儿科人群）的药物药代动力学时，这种方法很有用。鉴于临床试验很少纳入新生儿人群，PBPK建模对于新生儿群体的剂量优化是一个特别重要的工具。然而，新生儿存在重要的知识空白，导致模型预测存在不确定性。本综述旨在概述在开发新生儿PBPK模型时应考虑的变异性来源、目前可获得的新生儿个体发育数据，最后强调需要进一步研究的数据空白。
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