Institute of Chinese Medical Sciences (ICMS), State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Macau; Department of Public Health and Medicinal Administration, Faculty of Health Sciences, University of Macau, Macau.
Institute of Chinese Medical Sciences (ICMS), State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Macau; Department of Public Health and Medicinal Administration, Faculty of Health Sciences, University of Macau, Macau.
Drug Discov Today. 2022 Aug;27(8):2100-2120. doi: 10.1016/j.drudis.2022.04.015. Epub 2022 Apr 19.
Physiologically based pharmacokinetic (PBPK) modeling is an important in silico tool to bridge drug properties and in vivo PK behaviors during drug development. Over the recent decade, the PBPK method has been largely applied to drug delivery systems (DDS), including oral, inhaled, transdermal, ophthalmic, and complex injectable products. The related therapeutic agents have included small-molecule drugs, therapeutic proteins, nucleic acids, and even cells. Simulation results have provided important insights into PK behaviors of new dosage forms, which strongly support drug regulation. In this review, we comprehensively summarize recent progress in PBPK applications in drug delivery, which shows large opportunities for facilitating drug development. In addition, we discuss the challenges of applying this methodology from a practical viewpoint.
生理药代动力学（PBPK）建模是一种重要的计算工具，可在药物开发过程中连接药物性质和体内 PK 行为。在最近十年中，PBPK 方法已广泛应用于药物传递系统（DDS），包括口服、吸入、透皮、眼科和复杂的注射产品。相关的治疗剂包括小分子药物、治疗性蛋白质、核酸，甚至细胞。模拟结果提供了对新型剂型 PK 行为的重要见解，这为药物监管提供了有力支持。在这篇综述中，我们全面总结了 PBPK 在药物传递中的应用进展，这为促进药物开发提供了巨大的机会。此外，我们还从实际角度讨论了应用该方法学的挑战。
