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小标题characterizations of purified recombinant proteins.更小的标题stability,storage,sterility.第一段stability studies include the evaluation of those protein features that are susceptible to change during storage and might influence the quality safety ,and efficacy .the testing should cover physical,biological aspects,as well as the preservative content such as antioxidants or antimicrobials.第二段stability-indicating assays are validated quantitative analytical procedures that can detect drug alterations over time. they should include tests for integrity of the drug,potency,sterility,and,if applicable,moisture,and preservative stability measured at regular intervals throughout the dating period.

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红笺小字: 金币+10, 翻译EPI+1, 谢谢,翻译的挺好的! 2012-11-24 00:32:33
红笺小字: 回帖置顶 2012-11-29 23:18:18
纯化的重组蛋白的特征
稳定性,储存,无菌
第一段
稳定性研究包括,对在储存过程中容易发生改变并可能影响安全性和有效性的蛋白质特征的评价,测试应该涵盖物理、生物方面,同样也包括防腐剂如抗氧化剂或抗微生物剂的含量。
第二段
稳定性指示分析是被验证了的定量分析方法,可以检测出药物随着时间的改变。该分析程序包括到期前的药物完整性,效力,无菌性,如果有需要,还有湿度、防腐剂的稳定性的定期测定。
2楼2012-11-23 23:54:31
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