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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 대한약리학회 The Korean Journal of Physiology & Pharmacology The Korean Journal of Physiology & Pharmacology 제21권 제1호
- 발행연도
- 2017.1
- 수록면
- 107 - 115 (9page)
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초록· 키워드
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Over the last decade, physiologically based pharmacokinetics (PBPK) application has been extended significantly not only to predicting preclinical/ human PK but also to evaluating the drug-drug interaction (DDI) liability at the drug discovery or development stage. Herein, we describe a case study to illustrate the use of PBPK approach in predicting human PK as well as DDI using in silico, in vivo and in vitro derived parameters. This case was composed of five steps such as: simulation, verification, understanding of parameter sensitivity, optimization of the parameter and final evaluation. Caffeine and ciprofloxacin were used as tool compounds to demonstrate the “fit for purpose” application of PBPK modeling and simulation for this study. Compared to caffeine, the PBPK modeling for ciprofloxacin was challenging due to several factors including solubility, permeability, clearance and tissue distribution etc. Therefore, intensive parameter sensitivity analysis (PSA) was conducted to optimize the PBPK model for ciprofloxacin. Overall, the increase in Cmax of caffeine by ciprofloxacin was not significant. However, the increase in AUC was observed and was proportional to the administered dose of ciprofloxacin. The predicted DDI and PK results were comparable to observed clinical data published in the literatures. This approach would be helpful in identifying potential key factors that could lead to significant impact on PBPK modeling and simulation for challenging compounds.
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참고문헌 (31)
참고문헌 신청
Hosea NA / 2013 / Predicting pharmacokinetic profiles using in silico derived parameters / Mol Pharm 10:1207~1215
Krayenbühl JC / 1999 / Drugdrug interactions of new active substances : mibefradil example / Eur J Clin Pharmacol 55:559~565
Bjornsson TD / 2003 / The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective / J Clin Pharmacol 43:443~469
Einolf HJ / 2007 / Comparison of different approaches to predict metabolic drug-drug interactions / Xenobiotica 37:1257~1294
Almond LM / 2009 / Towards a quantitative framework for the prediction of DDIs arising from cytochrome P450 induction / Curr Drug Metab 10:420~432
Krayenbühl JC / 1999 / Drugdrug interactions of new active substances : mibefradil example / Eur J Clin Pharmacol 55:559~565
Bjornsson TD / 2003 / The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective / J Clin Pharmacol 43:443~469
Einolf HJ / 2007 / Comparison of different approaches to predict metabolic drug-drug interactions / Xenobiotica 37:1257~1294
Almond LM / 2009 / Towards a quantitative framework for the prediction of DDIs arising from cytochrome P450 induction / Curr Drug Metab 10:420~432
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