Opportunities and challenges of physiologically based pharmacokinetic modeling in drug delivery

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 smallmolecule 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.

Automated summary

PBPK modeling is a crucial tool to bridge drug properties and in vivo PK behaviors during drug development, especially in drug delivery systems. The simulation results provide important insights into new dosage forms, supporting drug regulation. However, practical challenges exist in applying this methodology.