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重组艾塞那肽-人血白蛋白融合蛋白检定
释义
重组艾塞那肽-人血白蛋白融合蛋白检定
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医学
重组艾塞那肽-人血白蛋白融合蛋白检定
释
testing for recombinant exendin-4/HSA fusion protein
重组艾塞那肽-人血白蛋白融合蛋白检定
依据药品质量标准,采用适当的检验方法和标准物质,对应用重组脱氧核糖核酸(DNA)技术制备的重组艾塞那肽-人血白蛋白融合蛋白(E2HSA)的理化性质、含量、生物学活性、纯度、杂质及安全性等各类检验项目进行检测分析,以确定其是否符合药品标准规定的检验活动,是保证重组艾塞那肽-人血白蛋白融合蛋白药物安全、有效、质量可控的重要环节。
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