聚乙二醇化重组人粒细胞集落刺激因子注射液单次给药健康人体Ⅰ期临床药代动力学及药效动力学研究

来源 :2015第11届全国药物和化学异物代谢学术会议 | 被引量 : 0次 | 上传用户:NobelHsu
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  目的 研究注射用重组人成纤维细胞生长因子-21 (FGF-21)在食蟹猴体内单次、多次给药后的药代动力学特征,并比较单次与多次给药后的药代动力学行为的变化.方法 采用随机、平行和剂量递增设计,18只食蟹猴分别单次s.c.150、300、600 μg·kg-1或多次s.c.300 μg·kg-1 FGF-21,采用双抗体夹心ELISA法检测血清中药物浓度的动态变化,用DAS 3.2.4药动程序拟合并计算药动学参数.
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