Evaluation of the toxicology and pharmacokinetics of recombinant factor VIII Fc fusion protein in animals
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- 作者：Jennifer A. Dumont ; jennifer.dumont@biogen.com" class="auth_mail" title="E-mail the corresponding author ; Kenneth S. Loveday kenneth.loveday@biogen.com" class="auth_mail" title="E-mail the corresponding author ; David R. Light david.light@biogen.com" class="auth_mail" title="E-mail the corresponding author ; Glenn F. Pierce glennfpierce@gmail.com" class="auth_mail" title="E-mail the corresponding author ; Haiyan Jiang haiyan.jiang@biogen.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：aPTT ; activated partial thromboplastin time ; AUC&infin ; area under the curve from zero to time infinity ; AUClast ; area under the curve up to the last measurable concentration ; BW ; body weight ; CL ; clearance ; Cmax ; maximum plasma concentration ; ECG ; electrocardiogram ; ELISA ; enzyme-linked immunosorbent assay ; F ; female ; FcRn ; neonatal Fc receptor ; FVIII ; factor VIII ; GLP ; Good Laboratory Practice ; HEK ; human embryonic kidney ; HR ; heart rate ; IgG1 ; immunoglobulin G1 ; M ; male ; MRT ; mean residence
- 刊名：Thrombosis Research
- 出版年：2015
- 出版时间：December 2015
- 年：2015
- 卷：136
- 期：6
- 页码：1266-1272
- 全文大小：426 K
文摘
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Recombinant factor VIII Fc fusion protein (rFVIIIFc) is a longer-acting FVIII.
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Repeat (rats and monkeys) and high (monkeys) dosing of rFVIIIFc was well tolerated.
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There were no local tolerance findings at infusion sites with repeated dosing.
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There was no evidence of thrombosis at high doses (up to 20,000 IU/kg) in monkeys.
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No toxicological effects were directly related to rFVIIIFc in rats or monkeys.
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