生理药动学模型在生物等效性研究中的应用

Application of Physiologically Based Pharmacokinetic Models in Bioequivalence Study

生理药动学(physiologically based pharmacokinetics,PBPK)建模综合了药物理化性质、处方因素和生理因素,是研究药物动力学行为的重要工具,能模拟和预测药物的体内命运,分析众多参数对药物生物利用度和生物等效性的影响。在药品的开发、工艺变更和质量控制方面有广泛应用,可减少研发费用、缩短研发周期。本研究简要介绍了PBPK模型的研究进展及建模思路,并从处方筛选、食物效应、药物性质、生物等效豁免等方面讨论了PBPK模型在生物等效性研究中的应用,为仿制药开发提供思路。

Physiologically based pharmacokinetic(PBPK)modeling is an essential instrument for studying pharmacokinetic behaviors by integrating the physicochemical properties of drugs,formulation factors,and physiological factors.It can simulate and predict the fates of drugs in vivo and explore the effects of various parameters on drug bioavailability and bioequivalence.It is commonly used in developing drugs,process variation,and quality control,which can reduce expenses and cycle of research and development.This paper briefly introduces the research progress and modeling ideas of the PBPK models.Moreover,the applications of PBPK model in bioequivalence researches on prescription screening,food effects,drug properties,and biowaiver are discussed to provide novel ideas for developing corresponding models for generic drugs.