Advanced search
Publication Cover
Drug Design, Development and Therapy Volume 14, 2020 - Issue
Submit an article Journal homepage
108
Views
4
CrossRef citations to date
0
Altmetric
Original Research

Contribution of Trough Concentration Data in the Evaluation of Multiple-Dose Pharmacokinetics for Drugs with Delayed Distributional Equilibrium and Long Half-Life

Suein Choi1 Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, The Catholic University of Korea, Seoul, Korea;2 Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, KoreaORCID Iconhttps://orcid.org/0000-0001-5438-7819
ORCID Icon,
Sangil Jeon3 Q-Fitter, Seoul, Korea
,
Dong-Seok Yim1 Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, The Catholic University of Korea, Seoul, Korea;2 Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, KoreaORCID Iconhttps://orcid.org/0000-0003-2754-7500
ORCID Icon &
Seunghoon Han1 Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, The Catholic University of Korea, Seoul, Korea;2 Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, KoreaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-9976-5120
ORCID Icon
Pages 811-821 | Published online: 25 Feb 2020

References

  • Center for Drug Evaluation and Research (CDER) Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drug submitted under an ANDA. Food and Drug Administration; 2013 Available from: https://www.fda.gov/media/87219/download. Accessed 1231, 2019.
  • European Medicines Agency. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. EMEA; 2014 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf. Accessed 1231, 2019.
  • TernantD, PassotC, AubourgA, et al. Model-based therapeutic drug monitoring of infliximab using a single serum trough concentration. Clin Pharmacokinet. 2018;57(9):1173–1184. doi:10.1007/s40262-017-0621-629236229
  • WangY, ChiaYL, NedelmanJ, SchranH, MahonFX, MolimardM. A therapeutic drug monitoring algorithm for refining the imatinib trough level obtained at different sampling times. Ther Drug Monit. 2009;31(5):579–584. doi:10.1097/FTD.0b013e3181b2c8cf19730279
  • SchmittC, PortronA, JadidiS, SarkarN, DiMarchiR. Pharmacodynamics, pharmacokinetics and safety of multiple ascending doses of the novel dual glucose‐dependent insulinotropic polypeptide/glucagon‐like peptide‐1 agonist RG7697 in people with type 2 diabetes mellitus. Diabetes Obes Metab. 2017;19(10):1436–1445. doi:10.1111/dom.1302428730694
  • LinCW, DuttaS, AsatryanA, et al. Pharmacokinetics, safety, and tolerability following single and multiple doses of pibrentasvir in a first-in-human study. Clin Pharmacol Drug Dev. 2018;7(1):44–52. doi:10.1002/cpdd.35028464496
  • YiS, KimTE, YoonSH, et al. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011;57(6):682–689. doi:10.1097/FJC.0b013e31821795d021394036
  • HeoYA, HolfordN, KimY, SonM, ParkK. Quantitative model for the blood pressure-lowering interaction of valsartan and amlodipine. Br J Clin Pharmacol. 2016;82(6):1557–1567. doi:10.1111/bcp.1308227504853
  • KangWY, SeongSJ, OhkB, et al. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects. Drug Des Devel Ther. 2018;(12):545–553. doi:10.2147/DDDT.S156492
  • DuanJ, ChenJ, YinQ, et al. Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects. Int J Clin Pharmacol Ther. 2012;50(1):33–43. doi:10.5414/CP20160122192643
  • Norvasc® (amlodipine besylate) [package insert]. New York: Pfizer 2011
  • KarlssonM, NordgrenR, FreibergaS, UeckertS, YngmanG Perl-speaks-NONMEM (PsN) 4.9.0. SSE user’s guide. Uppsala, Sweden;2018 Available from: https://uupharmacometrics.github.io/PsN/docs.html. Accessed 1231, 2019.
  • HookerAC, StaatzCE, KarlssonMO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res. 2007;24(12):2187–2197. doi:10.1007/s11095-007-9361-x17612795
  • HanYR, LeePI, PangKS. Finding Tmax and Cmax in multicompartmental models. Drug Metab Dispos. 2018;46(11):1796–1804. doi:10.1124/dmd.118.08263630135243
  • FitzmauriceGM, DavidianM, VerbekeG, MolenberghsG. Longitudinal Data Analysis. Boca Raton: Chapman & Hall; 2008.
  • SavicRM, KarlssonMO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11(3):558–569. doi:10.1208/s12248-009-9133-019649712
  • XuXS, YuanM, KarlssonMO, DunneA, NandyP, VermeulenA. Shrinkage in nonlinear mixed-effects population models: quantification, influencing factors, and impact. AAPS J. 2012;14(4):927–936. doi:10.1208/s12248-012-9407-922993107

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.