基于生理学的药代动力学模型
生物制药
IVIVC公司
生化工程
生物利用度
药代动力学
药物开发
生物制药分类系统
药理学
计算机科学
化学
药品
管理科学
风险分析(工程)
医学
工程类
溶解试验
体外
生药学
生物活性
生物化学
作者
Saima Subhani,Chaejin Kim,Paula Muniz,M. Rodríguez,Sandra van Os,Eduardo Viñuela Súárez,Rodrigo Cristofoletti,Stephan Schmidt,Valvanera Vozmediano
标识
DOI:10.1016/j.ejpb.2022.05.007
摘要
Physiologically based pharmacokinetic (PBPK) modeling for biopharmaceutics applications holds great promise as modelling and simulation tool in the field of modern oral modified release (MR) products. Understanding of gastro-intestinal absorption related processes is crucial to ensure the successful development of complex oral drug generic products. In the recent years, PBPK approach has been gradually influencing decision making ability of pharmaceutical industry as well as regulatory agencies. However, there is a gap in understanding its contribution in the field of oral modified release products. In this review, we have collected different recent research articles illustrating the significant contribution of PBPK to the research and development process of oral MR products, with special emphasis on generic drug products. Concretely, literature examples on the utility of PBPK formulation development, for in vitro- in vivo correlations (IVIVC) and prediction of oral bioavailability, and for in-silico food effect predictions were included in the review.
科研通智能强力驱动
Strongly Powered by AbleSci AI