Integrated pharmacokinetic-pharmacodynamic modeling and allometric scaling for optimizing the dosage regimen of the monoclonal ior EGF/r3 antibody

European Journal of Pharmaceutical Sciences

Volumn 21, Issue 2-3, 2004, Pages 261-270

  Duconge, Jorge ^a   Castillo, Rubén ^a   Crombet, Tania ^b   Alvarez, Daniel ^a   Matheu, Janet ^a   Vecino, Gloria ^a   Alonso, Katia ^a   Beausoleil, Irene ^b   Valenzuela, Carmen ^c   Becquer, Maria A ^a   Fernández Sánchez, Eduardo ^a  

^a UNIVERSITY OF HAVANA   (Cuba)

^b CENTER OF MOLECULAR IMMUNOLOGY   (Cuba)

^c CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY   (Cuba)

Author keywords

Allometric scaling; Dosage regimen; Integrated pharmacokinetic pharmacodynamic; Monoclonal antibody ior EGF r3; Survival time; Tumor growth delay

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR ANTIBODY; MONOCLONAL ANTIBODY;

ALLOMETRY; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CANCER INHIBITION; CONTROLLED STUDY; DRUG DOSE REGIMEN; DRUG TISSUE LEVEL; HUMAN; HUMAN CELL; MALE; MATHEMATICAL COMPUTING; MOUSE; MULTIPLE DRUG DOSE; NONHUMAN; NUDE MOUSE; OPTIMAL DRUG DOSE; PREDICTION; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE; STEADY STATE; SURVIVAL TIME; XENOGRAFT;

EID: 0742304308     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2003.10.015     Document Type: Article

References (22)

1. Alvan G., Helleday L., Lindholm A., Sanz E., Villen T. Diuretic effect and diuretic efficiency after intravenous dosage of furosemide. Br. J. Clin. Pharmacol. 29:1990;215-219.
2. Boxenbaum H. Interspecies scaling, allometry, physiological time and the ground plan for pharmacokinetics. J. Pharmacokin. Biopharm. 10:1982;201-207.
3. Boxenbaum H. Time concepts in physics, biology and pharmacokinetics. J. Pharm. Sci. 75(11):1986;1053-1062.
4. Boxenbaum H., DiLea C. First time in human dose selection: allometric thoughts and perspectives. J. Clin. Pharmacol. 35:1995;957-965.
5. Duconge J., Fernández-Sánchez E., Macias A., Castillo R., Garcia I., Beausoleil I., Amador J.F., Matheu J. Monoclonal anti-egf receptor antibody (ior-R3) pharmacokinetic study in tumor bearing nude mice: role of the receptor-mediated endocytosis on drug clearance. Eur. J. Drug Metab. Pharmacokinet. 27(2):2002;101-105.
6. Fan Z., Baselga J., Masui H., Mendelsohn J. Antitumor effect of anti-EGF receptor monoclonal antibodies plus cis-diamminedichloroplatinum on web established A431 cell xenografts. Cancer Res. 53:1993;4637-4642.
7. Fernández A., Pérez R., Macías A., Velanda A., Alvarez I., Ramos M., Velozo A. Generación y caracterización primaria de anticuerpos monoclonales contra el receptor del factor de crecimiento epidérmico. Interferón y Biotecnología. 6(3):1989;289-298.
8. Gabrielsson, J., Weiner, D., 1997. Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Swedish Pharmaceutical Press, Stockholm.
9. Grizzle J.E., Allen D.M. Analysis of growth and dose response curves. Biometrics. 25:1969;357-381.
10. Holford N.H.G., Sheiner L.B. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clinical Pharmacokin. 6:1981;429-453.
11. Jain R.K., Baxter L.T. Mechanism of heterogeneous distribution of MAb and other macromolecules in tumors: Significance of elevated interstitial pressure. Cancer Res. 48:1988;7022-7032.
12. Jain R.K. Physiological barriers to delivery of MAb and other macromolecules in tumors. Cancer Res. 50:1990;814-819.
13. Kaojarern S., Day B., Brater D.C. The time course of delivery of furosemide into urine: an independent determinant of overall response. Kidney Int. 22:1982;69-74.
14. Levy, G., 1993. The case for preclinical Pharmacodynamic. In: Yacobi, A., Skelly, J.P., Shah, V.P., Benet, L.Z. (Eds.), Integration of Pharmacokinetic, Pharmacodynamic and Toxicokinetics in Rational Drug Development. Plenum Press, New York, pp. 7-13.
15. Mantel N. Evaluation of survival data and two new rank order statistics arising in its considerations. Cancer Chemother. Rep. 50:1966;163-170.
16. Mendelsohn J. Anti-EGF receptor MAb may inhibit A431 tumor cell proliferation by blocking on autocrine pathway. Trans. Assoc. Am Physicians. 100:1987;173-178.
17. Mordenti J. Man versus beast: pharmacokinetic scaling in mammals. J. Pharm. Sci. 75(11):1986;1028-1040.
18. Peck, C.C., 1995. Rationale for the effective use of pharmacokinetic and pharmacodynamic in early drug development. In: Yacobi, A., Skelly, J.P., Shah, V.P. (Eds.), Integration of Pharmacokinetic, Pharmacodynamic and Toxicokinetics in Rational Drug Development. Plenum Press, New York, pp. 1-5.
19. Reigner B.G., Williams P.E.O., Patel I.H., Steimer J.L., Peck C.C., Van Brummelen P. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development: Experience within Hoffmann La Roche. Clin. Pharmacokinet. 33(2):1997;142-151.
20. Rowland, M., Tozer, T.N., 1989. Multiple-dose regimens. In: Clinical Pharmacokinetics: Concepts and Applications, 2nd edition. Lea and Febiger, Philadelphia, pp. 78-100.
21. Sheiner L.B., Staski R., Vozeh A., Miller R.D., Ham J. Simultaneous modeling of pharmacokinetic and pharmacodynamic: Application to D-tubocurarine. Clin. Pharmacokinet. 1:1979;358-371.
22. Wagner J.G. Blood levels of the equilibrium state after multiple dosing. Nature. 107:1965;1391-1402.