Population modeling of filgrastim PK-PD in healthy adults following intravenous and subcutaneous administrations

Journal of Clinical Pharmacology

Volumn 50, Issue 9, 2010, Pages

  Krzyzanski, Wojciech ^a   Wiczling, Pawel ^b   Lowe, Phil ^c   Pigeolet, Etienne ^c   Fink, Martin ^c   Berghout, Alexander ^d   Balser, Sigrid ^d  

^a UNIVERSITY AT BUFFALO   (United States)

^b MEDICAL UNIVERSITY OF GDANSK   (Poland)

^c NOVARTIS PHARMA AG   (Switzerland)

^d Sandoz Pharma Ltd   (Switzerland)

Author keywords

Granulocyte colony stimulating factor; granulopoiesis; mechanistic models; neutrophils; target mediated drug disposition

Indexed keywords

RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ARTICLE; COMPUTER SIMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NEUTROPHIL COUNT; NONLINEAR SYSTEM; NORMAL HUMAN; POPULATION MODEL;

ADULT; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FILGRASTIM; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEUTROPHILS; NONLINEAR DYNAMICS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, GRANULOCYTE COLONY-STIMULATING FACTOR; YOUNG ADULT;

EID: 78449300746     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010376966     Document Type: Article

References (39)

1. Demetri GD, Griffin JD Granulocyte colony-stimulating factor and its receptor. Blood. 1991 ; 78: 2791-2808.
2. Anderlini P., Champlin RE Biologic and molecular effects of granulocyte colony-stimulating factor in normal individuals: recent findings and current challenges. Blood. 2008 ; 111: 1767-1772.
3. Robinson CR Reduce, reuse, and recycle. Nat Biotechnol. 2002 ; 20: 879-880.
4. Skubitz KM Neutrophilic leukocytes. In: Wintrobe MM, Greer J, eds. Wintrobe's Clinical Hematology. 11th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2004.
5. Bishop CR, Rothstein G., Ashenbrucker HE, Athens JW Leukokinetic studies. XIV. Blood neutrophil kinetics in chronic, steady-state neutropenia. J Clin Inv. 1971 ; 50: 1678-1689.
6. McKenzie SB Textbook of Hematology. Baltimore, MD: Williams and Williams ; 1996.
7. Walte K., Gabrilove J., Bronchud MH, Platzer E., Morstyn G. Filgrastim (r-metHuG-CSF): the first 10 years. Blood. 1996 ; 88: 1907-1929.
8. Spiekermann K., Roesler J., Emmendoerffer A., Elsner J., Welte K. Functional features of neutrophils induced by G-CSF and GM-CSF treatment: differential effects and clinical implications. Leukemia. 1997 ; 11: 466-478.
9. van Os R., van Schie ML, Willemze R., Fibbe WE Proteolytic enzyme levels are increased during granulocyte colony-stimulating factor-induced hematopoietic stem cell mobilization in human donors but do not predict the number of mobilized stem cells. J Hematother Stem Cell Res. 2002 ; 11: 513-521.
10. Sung L., Dror Y. Clinical applications of granulocyte-colony stimulating factor. Front Biosci. 2007 ; 12: 1988-2002.
11. Borleffs JC, Bosschaert M., Vrehen HM, et al. Effect of escalating doses of recombinant human granulocyte colony-stimulating factor (filgrastim) on circulating neutrophils in healthy subjects. Clin Ther. 1998 ; 20: 722-736.
12. Wang B., Ludden TM, Cheung EN, Schwab GG, Roskos LK Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers. J Pharmacokinet Pharmacodyn. 2001 ; 28: 321-342.
13. Kuwabara T., Uchimura T., Kobayashi H., Kobayashi S., Sugiyama Y. Receptor-mediated clearance of G-CSF derivative nartograstim in bone marrow of rats. Am J Physiol. 1995 ; 269: E1 - E9.
14. Layton JE, Hockman H., Sheridan WP, Morstyn G. Evidence for a novel in vivo control mechanism of granulopoiesis: mature cell-related control of a regulatory growth factor. Blood. 1989 ; 74: 1303-1307.
15. Foley C., Mackey MC Mathematical model for G-CSF administration after chemotherapy. J Theor Biol. 2009 ; 257: 27-44.
16. Roskos LK, Lum P., Lockbaum P., Schwab G., Yang BB Pharmacokinetic/ pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol. 2006 ; 46: 747-757.
17. Wiczling P., Lowe P., Pigeolet E., Ludicke F., Balser S., Krzyzanski W. Population phramacokinetic modelling of filgrastim in healthy adults following intravenous and subcutaneous administrations. Clin Pharmacokinet. 2009 ; 48: 817-826.
18. Levy G. Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther. 1994 ; 56: 248-252.
19. Mager DE, Jusko WJ General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokin Pharmacodyn. 2001 ; 28: 507-532.
20. Ng CM, Stefanich E., Anand BS, Fielder PJ, Vaickus L. Pharmacokinetics/pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers. Pharm Res. 2006 ; 23: 95-103.
21. Mager DE, Jusko WJ Receptor-mediated pharmacokinetic/ pharmacodynamic model of interferon-beta 1a in humans. Pharm Res. 2002 ; 19: 1537-1543.
22. Woo S., Krzyzanski W., Jusko WJ Target-mediated pharmacokinetic and pharmacodynamic model of recombinant human erythropoietin (rHuEPO). J Pharmacokin Pharmacodyn. 2007 ; 34: 849-868.
23. Jin F., Krzyzanski W. Pharmacokinetic model of target-mediated disposition of thrombopoietin. AAPS Pharm Sci. 2004 ; 6: E9.
24. Sarkar CA, Lauffenburger DA Cell-level pharmacokinetic model of granulocyte colony-stimulating factor: implications for ligand lifetime and potency in vivo. Mol Pharmacol. 2003 ; 63: 147-158.
25. Vainstein V., Ginosar Y., Shoham M., Ranmar DO, Ianovski A., Agur Z. The complex effect of granulocyte colony-stimulating factor on human granulopoiesis analyzed by a new physiologically-based mathematical model. J Theor Biol. 2005 ; 234: 311-327.
26. Roskos L., Cheung E., Vincent M., Foote M., Morstyn G. Pharmacology of filgrastim (r-metHuG-CSF). In: Morstyn G, Dexter TM, Foote M, eds. Filgrastim (r-metHuG-CSF) in Clinical Practice. New York: M. Dekker; 1998.
27. Mager DE, Krzyzanski W. Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm Res. 2005 ; 22: 1589-1596.
28. Friberg LE, Henningsson A., Maas H., Nguyen L., Karlsson MO Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol. 2002 ; 20: 4713-4721.
29. Avalos BR, Gasson JC, Hedvat C., et al., Human granulocyte colony-stimulating factor: biologic activities and receptor characterization on hematopoietic cells and small cell lung cancer cell lines. Blood. 1990 ; 75: 851-857.
30. Sarkar CA, Lowenhaupt K., Horan T., Boone TC, Tidor B., Lauffenburger DA Rational cytokine design for increased lifetime and enhanced potency using pH-activated "histidine switching." Nature Biotech. 2002 ; 20: 908-913.
31. Spertini O., Kansas GS, Munro JM, Griffin JD, Tedder TF Regulation of leukocyte migration by activation of the leukocyte adhesion molecule-1 (LAM-1) selectin. Nature. 1991 ; 349: 691-694.
32. Krzyzanski W., Jusko WJ, Wacholtz MC, Minton N., Cheung WK, Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after multiple subcutaneous doses in healthy subjects. Eur J Pharm Sci. 2005 ; 26: 295-306.
33. Samtani MN, Perez-Ruixo JJ, Brown K., Cerneus D., Molloy C. Pharmacokinetic and pharmacodynamic modeling of pegylated thrombopoietin mimetic peptide (PEG-TPOm) after single intravenous dose in healthy subjects. J Clin Pharmacol. 2009 ; 49: 336-350.
34. Jonsson EN, Macintyre F., James I., Krams M., Marshall S. Bridging the pharmacokinetics and pharmacodynamics of UK-279,276 across healthy volunteers and stroke patients using mechanistically based model for target-mediated disposition. Pharm Res. 2005 ; 22: 1236-1246.
35. Yan X., Mager DE, Krzyzanski W. Selection between Michaelis-Menten and target-mediated drug disposition pharmacokinetic models. J Pharmacokinet Pharmacodyn. 2010 ; 37: 25-48.
36. Krzyzanski W., Ramakrishnan R., Jusko WJ Basic models for agents that alter production of natural cells. J Pharmacokin Biopharm. 1999 ; 27: 467-489.
37. Ramakrishnan R., Cheung WK, Wacholtz MC, Minton L., Jusko WJ Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J Clin Pharmacol. 2004 ; 44: 991-1002.
38. Perez-Ruixo JJ, Kimko HC, Chow AC, Piotrovsky W., Krzyzanski W., Jusko WJ Population cell lifespan models for effects of drugs following indirect mechanism of action. J Pharmacokin Pharmacodyn. 2005 ; 32: 767-793.
39. Black JW, Leff P. Operational models of pharmacological agonism. Proc R Soc Lond B Biol Sci. 1983 ; 220: 141-162.