生理药代动力学(PBPK)模型常用于表征各种复杂的临床情况下的药物体内PK变化,即各种内在和外在因素对药物体内PK的影响。在美国FDA的新药审评中,审评人员通过PBPK建模,有效分析了药物相互作用(DDI)、儿科临床研究、肝功能不全人群、遗传药理学和药物吸收等方面的复杂临床问题。本文结合最新的文献实例,阐述PBPK建模在FDA新药审评中的应用。 Physiological pharmacokinetics (PBPK) model is often used to characterize PK changes in vivo in a variety of complex clinical situations, ie, the effects of various intrinsic and extrinsic factors on PK in vivo. In the FDA review of new drugs, reviewers used PBPK modeling to effectively analyze the complex clinical issues in drug-drug interaction (DDI), pediatric clinical research, liver dysfunction populations, genetic pharmacology and drug absorption. This article combines the latest literature examples to illustrate the application of PBPK modeling in the review of new FDA drugs.