基于生理的药代动力学模型预测食物对口服药物吸收影响的性能：现状。

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.

Merck & Co, Inc, Kennilworth, New Jersey, USA.

CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):82-89. doi: 10.1002/psp4.12260. Epub 2017 Nov 23.

A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect predictions, ∼50% were predicted within 1.25-fold of observed, and 75% within 2-fold. Dissolution rate and precipitation time were commonly optimized parameters when PBPK modeling was not able to capture the food effect. The current work presents a knowledgebase for documenting PBPK experience to predict food effect.

进行了全面的文献检索和已发表的美国食品和药物管理局审查，以评估基于生理学的药代动力学（PBPK）模型是否可用于预测临床食物对口服药物吸收的影响。在 48 个预测的食物影响中，约 50%在观察到的 1.25 倍以内，75%在 2 倍以内。当 PBPK 模型无法捕捉食物影响时，通常会优化溶解速率和沉淀时间等参数。目前的工作为记录用于预测食物影响的 PBPK 经验知识库。