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

Autor: Sun Z; Institute of Clinical Pharmacology, Peking University, Beijing 100191, China; Department of Pharmacology, Xiangya School of Pharmaceutical Sciences, Central South University, Changsha 410013, China; Department of Pharmacy, Peking University First Hospital, Beijing 100034, China., Zhao N; Drug Clinical Trial institution, Peking University First Hospital, Beijing 100009, China., Zhao X; Drug Clinical Trial institution, Peking University First Hospital, Beijing 100009, China., Wang Z; Drug Clinical Trial institution, Peking University First Hospital, Beijing 100009, China., Liu Z; Department of Pharmacology, Xiangya School of Pharmaceutical Sciences, Central South University, Changsha 410013, China; Department of Clinical Pharmacology, Hunan Key Laboratory of Pharmacogenetics, and National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha 410008, China; Institute of Clinical Pharmacology, Engineering Research Center for applied Technology of Pharmacogenomics of Ministry of Education, Central South University, Changsha 410078, China. Electronic address: zqliu@csu.edu.cn., Cui Y; Institute of Clinical Pharmacology, Peking University, Beijing 100191, China; Department of Pharmacy, Peking University First Hospital, Beijing 100034, China; Department of Pharmaceutical Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China. Electronic address: cui.pharm@pkufh.com.
Jazyk: angličtina
Zdroj: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2024 Sep 01; Vol. 200, pp. 106838. Date of Electronic Publication: 2024 Jul 01.
DOI: 10.1016/j.ejps.2024.106838
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors have no conflicts of interest that are directly relevant to the content of this article.
(Copyright © 2024. Published by Elsevier B.V.)
Databáze: MEDLINE
Externí odkaz: