Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data

Drug Metabolism and Pharmacokinetics

Volumn 26, Issue 4, 2011, Pages 423-430

  Oitate, Masataka ^a   Masubuchi, Noriko ^a   Ito, Takashi ^a   Yabe, Yoshiyuki ^a   Karibe, Tsuyoshi ^a   Aoki, Takanori ^a   Murayama, Nobuyuki ^a   Kurihara, Atsushi ^a   Okudaira, Noriko ^a   Izumi, Takashi ^a  

^a DAIICHI SANKYO CO   (Japan)

Author keywords

Allometric scaling; Clearance; Distribution volume; Monoclonal antibody; Pharmacokinetics; Prediction

Indexed keywords

ADALIMUMAB; BASILIXIMAB; BEVACIZUMAB; CETUXIMAB; ETANERCEPT; INFLIXIMAB; MONOCLONAL ANTIBODY; OMALIZUMAB; PALIVIZUMAB; RITUXIMAB; TOCILIZUMAB; TRASTUZUMAB;

ACCURACY; ALLOMETRY; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DISTRIBUTION VOLUME; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; HAPLORHINI; HUMAN; NONHUMAN; PREDICTION; STEADY STATE;

EID: 80052599925     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.2133/dmpk.DMPK-11-RG-011     Document Type: Article

References (35)

1. Boxenbaum, H.: Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J. Pharmacokinet. Biopharm., 10: 201-227 (1982).
2. Boxenbaum, H.: Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab. Rev., 15: 1071-1121 (1984).
3. Mahmood, I.: Application of fixed exponent 0.75 to the prediction of human drug clearance: an inaccurate and misleading concept. Drug Metabol. Drug Interact., 24: 57-82 (2009).
4. Mahmood, I.: Role of fixed coefficients and exponents in the prediction of human drug clearance: how accurate are the predictions from one or two species? J. Pharm. Sci., 98: 2472-2493 (2009).
5. Boxenbaum, H. and DöSouza, R. W.: Interspecies pharmacokinetic scaling, biological design and neoteny. In Testa, B. (ed.): Advances in Drug Research, London, Academic Press, 1990, volume 19, pp. 139-196.
6. Mordenti, J. and Chappell, W.: The use of interspecies scaling in toxicokinetics. In Yacobi, A., Kelly, J. and Batra, V. (eds.): Toxicokinetics and New Drug Development, New York, Pergamon Press, 1989, pp. 42-96.
7. Chappell, W. R. and Mordenti, J.: Extrapolation of toxicological and pharmacological data from animals to humans. In Testa, B.(ed.): Advances in Drug Research, London, Academic Press, 1991, pp. 1-116.
8. Mahmood, I.: Interspecies scaling of protein drugs: prediction of clearance from animals to humans. J. Pharm. Sci., 93: 177-185(2004).
9. Mahmood, I.: Pharmacokinetic allometric scaling of antibodies: application to the first-in-human dose estimation. J. Pharm. Sci., 98: 3850-3861 (2009).
10. Ling, J., Zhou, H., Jiao, Q. and Davis, H. M.: Interspecies scaling of therapeutic monoclonal antibodies: initial look. J. Clin. Pharmacol., 49: 1382-1402 (2009).
11. Deng, R., Iyer, S., Theil, F. P., Mortensen, D. L., Fielder, P. J. and Prabhu, S.: Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: What have we learned? MAbs, 3: 61-66 (2011).
12. Adalimumab (Humira) New Drug Application [NDA]. Available at the website of PMDA (Pharmaceuticals and Medical Devices Agency): http://www.info.pmda.go.jp/shinyaku/P200800019/ index.html.
13. Bevacizumab (Avastin) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200700027/index.html.
14. Etanercept (Enbrel) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200500002/index.html.
15. Infliximab (Remicade) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200300015/index.html.
16. Omalizumab (Xolair) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200900001/index.html.
17. Basiliximab (Simulect) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200200005/index.html.
18. Cetuximab (Erbitux) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200800039/index.html.
19. Palivizumab (Synagis) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200200010/index.html.
20. Rituximab (Rituxan) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200100018/index.html.
21. Tocilizumab (Actemra) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200500016/index.html.
22. Trastuzumab (Herceptin) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200100003/index.html.
23. Daclizumab (Zenapax) Drug Approval Package: Available at the website of FDA: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113472.pdf.
24. Daclizumab (Zenapax) Drug Approval Package: Available at the website of FDA: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113476.pdf.
25. Golimumab (Simponi) Drug Approval Package: Available at the website of FDA: http://www.accessdata.fda.gov/drugsatfdaddocs/nda/2009/125289s000dClinPharmRdP1.pdf.
26. Golimumab (Simponi) Drug Approval Package: Available at the website of FDA: http://www.accessdata.fda.gov/drugsatfdaddocs/ nda/2009/125289s000dPharmRdP1.pdf.
27. Ustekinumab (Stelara) Drug Approval Package: Available at the website of FDA: http://www.accessdata.fda.gov/drugsatfdaddocs/nda/2009/125261s000{eth}ClinPharmR.pdf.
28. Ustekinumab (Stelara) Drug Approval Package: Available at the website of FDA: http://www.accessdata.fda.gov/drugsatfdaddocs/nda/2009/125261s000dPharmR.pdf.
29. Agus, D. B., Gordon, M. S., Taylor, C., Natale, R. B., Karlan, B., Mendelson, D. S., Press, M. F., Allison, D. E., Sliwkowski, M. X., Lieberman, G., Kelsey, S. M. and Fyfe, G.: Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J. Clin. Oncol., 23: 2534-2543(2005).
30. Adams, C. W., Allison, D. E., Flagella, K., Presta, L., Clarke, J., Dybdal, N., McKeever, K. and Sliwkowski, M. X.: Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol. Immunother., 55: 717-727 (2006).
31. Joshi, A., Bauer, R., Kuebler, P., White, M., Leddy, C., Compton, P., Garovoy, M., Kwon, P., Walicke, P. and Dedrick, R.: An overview of the pharmacokinetics and pharmacodynamics of efalizumab: a monoclonal antibody approved for use in psoriasis. J. Clin. Pharmacol., 46: 10-20 (2006).
32. Efalizumab (Raptiva) Drug Approval Package: Available at the website of FDA: http://www.accessdata.fda.gov/drugsatfdaddocs/nda/2003/125075d0000dRaptivadPharmrdP1.pdf.
33. Tabrizi, M. A., Tseng, C. M. and Roskos, L. K.: Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today, 11: 81-88 (2006).
34. Ober, R. J., Radu, C. G., Ghetie, V. and Ward, E. S.: Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int. Immunol., 13: 1551-1559 (2001).
35. Deng, R., Loyet, K. M., Lien, S., Iyer, S., DeForge, L. E., Theil, F. P., Lowman, H. B., Fielder, P. J. and Prabhu, S.: Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-alpha antibody and its neonatal Fc receptor variants in mice and cynomolgus monkeys. Drug Metab. Dispos., 38: 600-605 (2010).