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Impurity does not increase cancer risk

机译:杂质不会增加患癌症的风险

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摘要

An impurity,ethyl mesilate,found in batches of HIV medicine nelfinavir(Viracept),which resulted in a global recall of the product,does not increase patients'risk of developing cancer,says the European Medicines Agency(EMEA).The EMEA's Committee for Medicinal Products for Human Use confirmed this following research conducted by manufacturer Roche and validated by independent experts.The studies show that patients exposed to the highest levels of the genotoxic impurity received doses that were well below the threshold for DNA damage to occur.
机译:欧洲药品管理局(EMEA)表示,在一批艾滋病毒药物奈芬那韦(Viracept)中发现一种杂质甲硅烷基乙酯,导致该产品在全球范围内被召回,但不会增加患者罹患癌症的风险。用于人类的药用产品证实了由罗氏(Roche)制造商进行的这项研究,并得到了独立专家的验证。研究表明,暴露于最高遗传毒性杂质水平的患者所接受的剂量远低于发生DNA损伤的阈值。

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