PBPK Modeling: Empowering Drug Development and Precision Dosing in China.

Abstract

Physiologically based pharmacokinetic (PBPK) modeling, a cornerstone of model-informed drug development and model-informed precision dosing, simulates drug disposition in the human body by integrating physiological, biochemical, and physicochemical parameters. While PBPK modeling has advanced globally since the 1970s, China's adoption of this technology has followed a distinctive path, characterized by accelerated growth over the past 2 decades. This review provides a comprehensive analysis of China's contributions to PBPK modeling, addressing knowledge gaps in publication trends, application domains, and platform preferences. A systematic literature search yielded 266 original PBPK research articles from PubMed up to August 08, 2024. The analysis revealed that drug disposition and drug-drug interaction studies constitute the largest proportion of PBPK analyses in China. Chinese universities and hospitals emerge as the leading contributors to PBPK research among institutions in China. Although established commercial PBPK platform such as GastroPlus and Simcyp remain popular within the Chinese pharmaceutical industry, open-source platforms like PK-Sim are gaining significant traction in PBPK applications across China. This review underscores the transformative potential of PBPK modeling in drug development within China, offering valuable insights into future directions and challenges in the field.