Center for Pharmacometrics and System Pharmacology at Lake Nona (Orlando), Department of Pharmaceutics, College of Pharmacy, University of Florida, FL, USA.
Model Informed Development (MID), Dynakin, SLU., a CTI company, Bilbao, Spain.
Eur J Pharm Biopharm. 2022 Jul;176:87-94. doi: 10.1016/j.ejpb.2022.05.007. Epub 2022 May 19.
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.
生理药代动力学（PBPK）模型在生物药剂学中的应用具有广阔的前景，是现代口服缓释（MR）产品领域的建模和模拟工具。了解与胃肠道吸收相关的过程对于确保复杂的口服仿制药物产品的成功开发至关重要。近年来，PBPK 方法逐渐影响了制药行业和监管机构的决策能力。然而，人们对其在口服缓释产品领域的贡献仍存在理解上的差距。在这篇综述中，我们收集了不同的最新研究文章，说明了 PBPK 在口服缓释产品的研究和开发过程中的重要贡献，特别强调了仿制药产品。具体而言，综述中包括了 PBPK 制剂开发、体外-体内相关性（IVIVC）和口服生物利用度预测以及体内食物效应预测方面的文献实例。
