Theoretical considerations of target-mediated drug disposition models: Simplifications and approximations

Pharmaceutical Research

Volumn 29, Issue 3, 2012, Pages 866-882

  Ma, Peiming ^a  

^a AMGEN INC   (United States)

Author keywords

Michaelis Menten; Quasi steady state; Rapid binding; Target mediated disposition

Indexed keywords

BETA1A INTERFERON; EFALIZUMAB; NEOPTERIN; DRUG;

ARTICLE; COMPARTMENT MODEL; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG BINDING; DRUG DISPOSITION; DRUG TARGETING; HUMAN; INTERMETHOD COMPARISON; MICHAELIS CONSTANT; PRIORITY JOURNAL; SIMULATION; STEADY STATE; ANIMAL; BIOLOGICAL MODEL; COMPUTER SIMULATION; DRUG DELIVERY SYSTEM; PHARMACOKINETICS; PHARMACOLOGY;

ANIMALS; COMPUTER SIMULATION; DRUG DELIVERY SYSTEMS; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PHARMACOLOGY;

EID: 84858230439     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0615-2     Document Type: Article

References (29)

1. Mager D, Jusko W. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn. 2001;28(6):507-32.
2. Woo S, Krzyzanski W, Jusko W. Target-mediated pharmacokinetic and pharmacodynamic model of recombinant human erythropoietin (rHuEPO). J Pharmacokinet Pharmacodyn. 2007;34:849-68.
3. Krzyzanski W, Wiczling P, Lowe P, Pigeolet E, Fink M, Berghout A, et al. Population modeling of filgrastim PK-PD in healthy adults following intravenous and subcutaneous administrations. J Clin Pharmacol. 2010;50(9 suppl):101S-12S.
4. Jin F, Krzyzanski W. Pharmacokinetic model of target-mediated disposition of thrombopoietin. AAPS PharmSci. 2004;6(1) Article 9.
5. Mager D, Jusko W. Receptor-mediated pharmacokinetic pharmacodynamic model of interferon-β 1a in humans. Pharm Res. 2002;19(10):1537-43.
6. Eppler S, Combs D, Henry T, Lopez J, Ellis S, Yi JH, et al. A target-mediated model to describe the pharmacokinetics and hemodynamic effects of recombinant human vascular endothelial growth factor in humans. Clin Pharmacol Ther. 2002;72(1):20-32.
7. Dirks N, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633-59.
8. Levy G. Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther. 1994;56:248-52.
9. Hayashi N, Tsukamoto Y, Sallas W, Lowe P. A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab. Br J Clin Pharmacol. 2007;63 (5):548-61.
10. Bauer R, Dedrick R, White M, Murray M, Garovoy M. Population pharmacokinetics and pharmacodynamics of the anti-CD11a antibody hu1124 in human subjects with psoriasis. J Pharmacokinet Pharmacodyn. 1999;27(4):397-420.
11. Gibiansky L, Gibiansky E. Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic and pharmacodynamic modeling of biologics. Expert Opin Drug Metab Toxicol. 2009;5(7):803-12.
12. Mager D, Krzyzanski W. Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm Res. 2005;22(10):1589-96.
13. Gibiansky L, Gibiansky E, Kakkar T, Ma P. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn. 2009;35:573-91.
14. Peletier L, Gabrielsson J. Dynamics of target-mediated drug disposition. European J Pharm Sci. 2009;38:445-64.
15. Jonsson E, Macintyre F, James I, Krams M, Marshall S. Bridging the pharmacokinetics and pharmacodynamics of UK-279,276 across healthy volunteers and stroke patients using a mechanistically based model for target-mediated disposition. Pharm Res. 2005;22:1236-46.
16. Klonowski W. Simplifying principles for chemical and enzyme reaction kinetics. Biophy Chem. 1983;18:73-83.
17. Segel L, Slemrods M. The quasi-steady-state assumption: a case study in perturbation. SIAM Rev. 1989;31(3):446-77.
18. Segel I. Enzyme kinetics: behavior and analysis of rapid equilibrium and steady-state enzyme systems. New York: Wiley; 1975.
19. YanX,Mager D, Krzyzanski W. Selection between Michaelis-Menten and target-mediated drug disposition pharmacokinetic models. J Pharmacokinet Pharmacodyn. 2010;37:25-47.
20. Wang W, Wang E, Balthasar J. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84 (5):548-58.
21. van Bueren JJ Lammerts, Bleeker WK, Bøgh HO, Houtkamp M, Schuurman J, van de Winkel JGJ, et al. Effect of target dynamics on pharmacokinetics of a novel therapeutic antibody against the epidermal growth factor receptor: implications for the mechanisms of action. Cancer Res. 2006;66(15):7630-8.
22. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria; 2010. ISBN 3-900051-07-0. Available from: http://www.R-project.org.
23. Setzer RW. odesolve: Solvers for ordinary differential equations; 2008. R package version 0.5-20.
24. Ng C, Stefanich E, Anand B, Fielder P, Vaickus L. Pharmacokinetics/ pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers. Pharm Res. 2006;23(1):95-103.
25. Marathe A, Peterson M, Mager D. Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients. J Pharmacol Exp Ther. 2008;326:555-62.
26. Kakkar T, Sung C, Gibiansky L, Vu T, Narayanan A, Lin SL, et al. Population PK and IgE pharmacodynamic analysis of a fully human monoclonal antibody against IL4 receptor. Pharm Res. 2011;19(10):1537-43.
27. Gibiansky L, Sutjandra L, Doshi S, Zheng J, Sohn W, Peterson M, et al. Population pharmacokinetic analysis of denosumab in advanced cancer patients with solid tumors. In: American Conference of Pharmacometrics. San Diego, CA; 2011.
28. Gibiansky L, Gibiansky E. Irreversible binding (IB) and Michaelis-Menten (MM) approximations of the target-mediated drug disposition (TMDD) model. In: AAPS National Biotechnology Conference. San Francisco, CA; 2010.
29. Marathe A, Krzyzanski W, Mager D. Numerical validation and properties of a rapid binding approximation of a target-mediated drug disposition pharmacokinetic model. J Pharmacokinet Pharmacodyn. 2009;36:199-219.