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【旧闻】一例重组生物制品处方变更引发的风波 2015.04.07
Biosimilar 免疫原性 处方开发 研发注册 辅料

1998年，由抗EPO抗体诱发的纯红细胞再生障碍性贫血（PRCA）发生率突然升高，且大多发生在皮下注射Eprex（EPO alfa）的慢性肾损伤患者身上...In 1998, an increase in the incidence of pure red cell aplasia (PRCA) was observed that was associated with anti-erythropoieti...