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紅箋小字木蟲(chóng) (小有名氣)
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[求助]
從來(lái)沒(méi)翻譯過(guò)專業(yè)的文章,老師布置下來(lái)了,在嘗試,但進(jìn)度很慢...
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小標(biāo)題characterizations of purified recombinant proteins.更小的標(biāo)題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. [ 發(fā)自手機(jī)版 http://www.gaoyang168.com/3g ] |

新蟲(chóng) (小有名氣)
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純化的重組蛋白的特征 穩(wěn)定性,儲(chǔ)存,無(wú)菌 第一段 穩(wěn)定性研究包括,對(duì)在儲(chǔ)存過(guò)程中容易發(fā)生改變并可能影響安全性和有效性的蛋白質(zhì)特征的評(píng)價(jià),測(cè)試應(yīng)該涵蓋物理、生物方面,同樣也包括防腐劑如抗氧化劑或抗微生物劑的含量。 第二段 穩(wěn)定性指示分析是被驗(yàn)證了的定量分析方法,可以檢測(cè)出藥物隨著時(shí)間的改變。該分析程序包括到期前的藥物完整性,效力,無(wú)菌性,如果有需要,還有濕度、防腐劑的穩(wěn)定性的定期測(cè)定。 |
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