基于生理学的药代动力学模型
生物等效性
药代动力学
透皮
医学
药品
药理学
临床药理学
人口
药物开发
生物利用度
靶向给药
重症监护医学
多药
作者
Manoranjenni Chetty,Trevor N. Johnson,Sebastian Polak,Farzaneh Salem,Kosuke Doki,Amin Rostami-Hodjegan
标识
DOI:10.1016/j.addr.2018.08.013
摘要
Older patients are generally not included in Phase 1 clinical trials despite being the population group who use the largest number of prescription medicines. Physiologically based pharmacokinetic (PBPK) modelling provides an understanding of the absorption and disposition of drugs in older patients. In this review, PBPK models used for the prediction of absorption and exposure of drugs after parenteral, oral and transdermal administration are discussed. Comparisons between predicted drug pharmacokinetics (PK) and observed PK are presented to illustrate the accuracy of the predictions by the PBPK models and their potential use in informing clinical trial design and dosage adjustments in older patients. In addition, a case of PBPK modelling of a bioequivalence study on two controlled release products is described, where PBPK predictions reproduced the study showing bioequivalence in healthy volunteers but not in older subjects with achlorhydria, indicating further utility in prospectively identifying challenges in bioequivalence studies.
科研通智能强力驱动
Strongly Powered by AbleSci AI