کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10162249 1114324 2014 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Safety and Biosimilarity of ior®EPOCIM Compared with Eprex® Based on Toxicologic, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Safety and Biosimilarity of ior®EPOCIM Compared with Eprex® Based on Toxicologic, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat
چکیده انگلیسی
This study examined the safety, pharmacodynamic (PD), and pharmacokinetic (PK) biosimilarity of the human recombinant erythropoietin (EPO) products ior®EPOCIM and Eprex®following a 28-day repeated intravenous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 30, 300, and 600 I.U./kg of ior®EPOCIM or 600 I.U. of Eprex®. Adverse findings for both ior®EPOCIM and Eprex® were similar and were a consequence of thrombotic events (ulcerative skin lesions, swollen hock joints/lameness, stomach ulcers) and decreased body weight gains, all known adverse reactions to this class of drug in rats. With the exception of stomach ulcers, all other adverse findings were fully reversible. Neither drug stimulated the production of antidrug antibodies. As expected, ior®EPOCIM and Eprex® both increased reticulocyte, red blood cell, hemoglobin, and hematocrit levels in rats. The PK of EPO following dosing with ior®EPOCIM was well behaved and consistent with the literature. The results of this study imply that ior®EPOCIM and Eprex® had safety profiles, PD responses, and toxicokinetic profiles that were biosimilar. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:3432-3441, 2014
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3432-3441
نویسندگان
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