Prediction of human plasma concentration-time profiles of monoclonal antibodies from monkey data by a species-invariant time method

Drug Metabolism and Pharmacokinetics

Volumn 27, Issue 3, 2012, Pages 354-359

  Oitate, Masataka ^a   Nakayama, Shintaro ^a   Ito, Takashi ^a   Kurihara, Atsushi ^a   Okudaira, Noriko ^a   Izumi, Takashi ^a  

^a DAIICHI SANKYO CO   (Japan)

Author keywords

Monoclonal antibody; Species invariant time method

Indexed keywords

MONOCLONAL ANTIBODY;

ACCURACY; ANALYTIC METHOD; ANTIGEN BINDING; ARTICLE; COMPLEX DEDRICK PLOT; CONTROLLED STUDY; DOSE NORMALIZATION; DRUG DISTRIBUTION; ELEMENTARY DEDRICK PLOT; HUMAN; HUMAN VERSUS ANIMAL COMPARISON; NONHUMAN; PLASMA CONCENTRATION-TIME CURVE; PREDICTION; RELIABILITY; SPECIES INVARIANT TIME METHOD; STEADY STATE;

EID: 84863221758     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.2133/dmpk.DMPK-11-SH-059     Document Type: Article

References (19)

1. Oitate, M., Masubuchi, N., Ito, T., Yabe, Y., Karibe, T., Aoki, T., Murayama, N., Kurihara, A., Okudaira, N. and Izumi, T.: Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data. Drug Metab. Pharmacokinet., 26:423-430 (2011).
2. 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).
3. 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).
4. Dedrick, R.L.: Animal scale-up. J. Pharmacokinet. Biopharm., 1: 435-461 (1973).
5. Boxenbaum, H. and Ronfeld, R.: Interspecies pharmacokinetic scaling and the Dedrick plots. Am. J. Physiol., 245: R768-R775 (1983).
6. Boxenbaum, H.: Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab. Rev., 15: 1071-1121 (1984).
7. 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.
8. Halpern, W. G., Lappin, P., Zanardi, T., Cai, W., Corcoran, M., Zhong, J. and Baker, K. P.: Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol. Sci., 91: 586-599 (2006).
9. Furie, R., Stohl, W., Ginzler, E. M., Becker, M., Mishra, N., Chatham, W., Merrill, J. T., Weinstein, A., McCune, W. J., Zhong, J., Cai, W. and Freimuth, W.: Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res. Ther., 10: R109 (2008).
10. Bevacizumab (Avastin) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200700027/index.html.
11. Etanercept (Enbrel) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200500002/index.html.
12. Infliximab (Remicade) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200300015/index.html.
13. Omalizumab (Xolair) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200900001/index.html.
14. Basiliximab (Simulect) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200200005/index.html.
15. Cetuximab (Erbitux) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200800039/index.html.
16. Palivizumab (Synagis) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200200010/index.html.
17. Rituximab (Rituxan) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200100018/index.html.
18. Tocilizumab (Actemra) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200500016/index.html.
19. Trastuzumab (Herceptin) NDA: Available at the website of PMDA: http://www.info.pmda.go.jp/shinyaku/P200100003/index.html.