An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug |
Hong, Yunjung
(PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea)
Jeon, Sangil (Q-fitter, Inc.) Choi, Suein (PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea) Han, Sungpil (PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea) Park, Maria (PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea) Han, Seunghoon (PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea) |
1 | Seng Yue C, Ozdin D, Selber-Hnatiw S, Ducharme MP. Opportunities and challenges related to the implementation of model-based bioequivalence criteria. Clin Pharmacol Ther. 2019;105:350-362. DOI |
2 | Dusing R. Optimizing blood pressure control through the use of fixed combinations. Vasc Health Risk Manag. 2010;6:321-325. DOI |
3 | Lin CP, Tung YC, Hsiao FC, Yang CH, Kao YW, Lin YS, Chu YC, Chu PH. Fixed-dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2020;22:1846-1853. DOI |
4 | Foster DM. Noncompartmental versus compartmental approaches to pharmacokinetic analysis. In: Atkinson AJ Jr, Abernethy DR, Daniels CE, Dedrick RL, Markey SP, editors. Principles of clinical pharmacology. Amsterdam: Elsevier; 2007. p.89-105. |
5 | Simons LA, Chung E, Ortiz M. Long-term persistence with single-pill, fixed-dose combination therapy versus two pills of amlodipine and perindopril for hypertension: Australian experience. Curr Med Res Opin. 2017;33:1783-1787. DOI |
6 | U.S. Food and Drug Administration. Clinical drug interaction studies - cytochrome P450 enzyme- and transporter-mediated drug interactions guidance for industry [Internet]. Silver Spring: U.S. Food and Drug Administration, 2020 [cited 2020 Nov 20]. Available from: https://www.fda.gov/media/134581/download. |
7 | Lehr T, Staab A, Trommeshauser D, Schaefer HG, Kloft C. Semimechanistic population pharmacokinetic drug-drug interaction modelling of a long half-life substrate and itraconazole. Clin Pharmacokinet. 2010;49:53-66. DOI |
8 | Svensson EM, Acharya C, Clauson B, Dooley KE, Karlsson MO. Pharmacokinetic interactions for drugs with a long half-life-evidence for the need of model-based analysis. AAPS J. 2016;18:171-179. DOI |
9 | Choi S, Jeon S, Yim DS, Han S. Contribution of trough concentration data in the evaluation of multiple-dose pharmacokinetics for drugs with delayed distributional equilibrium and long half-life. Drug Des Devel Ther. 2020;14:811-821. DOI |
10 | Kim H, Han S, Cho YS, Yoon SK, Bae KS. Development of R packages: 'NonCompart' and 'ncar' for noncompartmental analysis (NCA). Transl Clin Pharmacol. 2018;26:10-15. DOI |
11 | U.S. Food and Drug Administration. Amlodipine prescribing information [Internet]. Silver Spring: U.S. Food and Drug Administration, 2020 [cited 2020 Nov 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211340s000lbl.pdf. |
12 | Maganti L, Panebianco DL, Maes AL. Evaluation of methods for estimating time to steady state with examples from phase 1 studies. AAPS J. 2008;10:141-147. DOI |
13 | U.S. Food and Drug Administration. Draft guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. Silver Spring: U.S. Food and Drug Administration, 2013 [cited 2020 Nov 20]. Available from: https://www.fdanews.com/ext/resources/files/12/12-05-13-ANDAGuidance.pdf. |
14 | Heo YA, Holford N, Kim Y, Son M, Park K. Quantitative model for the blood pressure-lowering interaction of valsartan and amlodipine. Br J Clin Pharmacol. 2016;82:1557-1567. DOI |
15 | Wang T, Wang Y, Lin S, Fang L, Lou S, Zhao D, Zhu J, Yang Q, Wang Y. Evaluation of pharmacokinetics and safety with bioequivalence of Amlodipine in healthy Chinese volunteers: Bioequivalence Study Findings. J Clin Lab Anal. 2020;34:e23228. DOI |
![]() |