Bioavailability, Pharmacokinetics, and Safety of Belimumab Administered Subcutaneously in Healthy Subjects

作者: Wendy W. Cai , Michele Fiscella , Cecil Chen , Z. John Zhong , William W. Freimuth

DOI: 10.1002/CPDD.54

关键词:

摘要: … (Ig) G1λ monoclonal antibody that binds and antagonizes the … trial was designed to evaluate the absolute bioavailability (F), … Eligible subjects were healthy men or women aged 18–55 …

参考文章(17)
Rong Deng, Feng Jin, Saileta Prabhu, Suhasini Iyer, Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opinion on Drug Metabolism & Toxicology. ,vol. 8, pp. 141- 160 ,(2012) , 10.1517/17425255.2012.643868
W Wang, EQ Wang, JP Balthasar, Monoclonal Antibody Pharmacokinetics and Pharmacodynamics Clinical Pharmacology & Therapeutics. ,vol. 84, pp. 548- 558 ,(2008) , 10.1038/CLPT.2008.170
Zhenhua Xu, Qingmin Wang, Yanli Zhuang, Bart Frederick, Hong Yan, Esther Bouman-Thio, Joseph C. Marini, Monica Keen, David Snead, Hugh M. Davis, Honghui Zhou, Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects The Journal of Clinical Pharmacology. ,vol. 50, pp. 276- 284 ,(2010) , 10.1177/0091270009340782
J. Manson, A. Rahman, D. A. Isenberg, J. C. Edwards, G. Cambridge, M. J. Leandro, M. Teodorescu, B cell depletion therapy in systemic lupus erythematosus: Effect on autoantibody and antimicrobial antibody profiles Arthritis & Rheumatism. ,vol. 54, pp. 3612- 3622 ,(2006) , 10.1002/ART.22211
Richard K.G. Do, Eunice Hatada, Hayyoung Lee, Michelle R. Tourigny, David Hilbert, Selina Chen-Kiang, Attenuation of Apoptosis Underlies B Lymphocyte Stimulator Enhancement of Humoral Immune Response Journal of Experimental Medicine. ,vol. 192, pp. 953- 964 ,(2000) , 10.1084/JEM.192.7.953
Greg L Plosker, Susan J Keam, Omalizumab BioDrugs. ,vol. 22, pp. 189- 204 ,(2008) , 10.2165/00063030-200822030-00005
Evelyn D. Lobo, Ryan J. Hansen, Joseph P. Balthasar, Antibody pharmacokinetics and pharmacodynamics. Journal of Pharmaceutical Sciences. ,vol. 93, pp. 2645- 2668 ,(2004) , 10.1002/JPS.20178
Joan T. Merrill, Ellen M. Ginzler, Daniel J. Wallace, James D. McKay, Jeffrey R. Lisse, Cynthia Aranow, Frank R. Wellborne, Michael Burnette, John Condemi, Z. John Zhong, Lilia Pineda, Jerry Klein, William W. Freimuth, , Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis & Rheumatism. ,vol. 64, pp. 3364- 3373 ,(2012) , 10.1002/ART.34564
Risto S Cvetkovi??, Lesley J Scott, Adalimumab: a review of its use in adult patients with rheumatoid arthritis. BioDrugs. ,vol. 20, pp. 293- 311 ,(2006) , 10.2165/00063030-200620050-00005
Daniel J. Wallace, William Stohl, Richard A. Furie, Jeffrey R. Lisse, James D. McKay, Joan T. Merrill, Michelle A. Petri, Ellen M. Ginzler, W. Winn Chatham, W. Joseph McCune, Vivian Fernandez, Marc R. Chevrier, Z. John Zhong, William W. Freimuth, A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Belimumab in Patients With Active Systemic Lupus Erythematosus Arthritis Care and Research. ,vol. 61, pp. 1168- 1178 ,(2009) , 10.1002/ART.24699