基于生理学的药代动力学(PBPK)模型可以利用临床前数据迅速预测药物的药代动力学特性,成为提高新药开发效率和质量的重要工具。在这次审查中,通过搜索FDA药品中的申请审查文件,我们分析了过去5年中PBPK模型在美国食品和药物管理局(FDA)批准的新药中的应用现状.根据结果,从2019年到2023年,FDA批准了243种新药。在此期间,74FDA批准的使用PBPK模型的新药的应用审查文件。PBPK模型用于各个领域,包括药物-药物相互作用(DDI),器官损害(OI)患者,儿科,药物-基因相互作用(DGI),疾病影响,和食物的影响。DDI是新药PBPK模型中使用最广泛的领域,占总数的74.2%。具有图形用户界面(GUI)的软件平台降低了PBPK建模的难度,Simcyp是申请者中最受欢迎的软件平台,使用率为80.5%。尽管面临挑战,PBPK已经证明了其在新药开发中的潜力,越来越多的成功案例为行业研究人员提供了经验。
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.