Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration

作者：Zexu Sun, Nan Zhao, Xia Zhao, Ziyang Wang, Zhaoqian Liu, Yimin Cui · 发表于：European Journal of Pharmaceutical Sciences · 年份：2024 · DOI：10.1016/j.ejps.2024.106838 · 被引用次数：61 · 研究领域：Pharmacogenetics and Drug Metabolism、Innovative Microfluidic and Catalytic Techniques Innovation、Receptor Mechanisms and Signaling

Physiologically based pharmacokinetic (PBPK) models which can leverage preclinical data to predict the pharmacokinetic properties of drugs rapidly became an essential tool to improve the efficiency and quality of novel drug development. In this review, by searching the Application Review Files in Drugs@FDA, we analyzed the current application of PBPK models in novel drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. According to the results, 243 novel drugs were approved by the FDA from 2019 to 2023. During this period, 74 Application Review Files of novel drugs approved by the FDA that used PBPK models. PBPK models were used in various areas, including drug-drug interactions (DDI), organ impairment (OI) patients, pediatrics, drug-gene interaction (DGI), disease impact, and food effects. DDI was the most widely used area of PBPK models for novel drugs, accounting for 74.2 % of the total. Software platforms with graphical user interfaces (GUI) have reduced the difficulty of PBPK modeling, and Simcyp was the most popular software platform among applicants, with a usage rate of 80.5 %. Despite its challenges, PBPK has demonstrated its potential in novel drug development, and a growing number of successful cases provide experience learned for researchers in the industry.