回复nanfeiyan9999发表于:2007/8/18 8:53:00悬赏金额:
20积分 状态:
已解决
1.Accuracy at the Potency Assay Level
被分析物准确度 (注释:Potency什么意思一直没明白?)
2.Method Linearity for Potency Assay
3.Placebo and Diluent Chromatogram
稀释液图谱?(注释:稀释液图谱上面的一句话,但我不明白为什么加Placebo,难道是将稀释后样品用空白溶剂Placebo来溶?)
4.Note: Complete vllidation tata for the proposed method are attached for your reference.
(注释:此为优化后方法测得数据表格下的一句话)
5. Equivalency Test Data for BM-55 for Injection
BM-55注射液等价试验数据(注释:这句下面有两个相同量的BM55在不同方法下的试验数据对比即优化前和优化后对比)
6. The method has been validated and is intended for use in testirig product at the time of release as well as on stability.
此方法已经过验证并用于释药期和稳定期的产物检测。(注释:release和stability可以这么翻译吗?)
原文由 nanfeiyan9999 发表: 我也刚入专业翻译不久,急需这样的指导.我也抓紧时间学习解决办法的途径. |
那你可以多看看药典的中英文版,或者找些药学类杂志看看中英文摘要。首先要了解专业知识,其次才是专业英语。祝你早日进步!
原文由 nanfeiyan9999 发表:
6. The method has been validated and is intended for use in testirig product at the time of release as well as on stability. 此方法已经过验证并用于释药期和稳定期的产物检测。(注释:release和stability可以这么翻译吗?) 此方法已经过验证,用于药物放行检测和稳定性检测。 放行检测是什么?是进口药物入关的检测?
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“Release” is a technical term in the field of Quality Control (see GB/T 19000—2000 Clause 3.6.13 放行 release : 对进入一个过程的下一阶段的许可). Different quality systems have different procedures for granting the release. Testing is generally an essential procedure.
I searched this term after reading the explanation in a post in this forum, you may visit
20/F of http://www.instrument.com.cn/bbs/shtml/20070708/902917/index_2.shtml
for use: 用於
is intended for use : 准备用於
原文由 nanfeiyan9999 发表:
6. The method has been validated and is intended for use in testirig product at the time of release as well as on stability. 此方法已经过验证并用于释药期和稳定期的产物检测。(注释:release和stability可以这么翻译吗?) 此方法已经过验证,用于药物放行检测和稳定性检测。 放行检测是什么?是进口药物入关的检测?
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testirig?=testing 放行是药物从一工序进入下一工序,一般QA许可。
原文由 nanfeiyan9999 发表: 4.Note: Complete vllidation tata for the proposed method are attached for your reference. (注释:此为优化后方法测得数据表格下的一句话) 注:附上建议方法的完整验证数据供参考 5. Equivalency Test Data for BM-55 for Injection BM-55注射液等价试验数据(注释:这句下面有两个相同量的BM55在不同方法下的试验数据对比即优化前和优化后对比)
可以了 6. The method has been validated and is intended for use in testirig product at the time of release as well as on stability. 此方法已经过验证并用于释药期和稳定期的产物检测。(注释:release和stability可以这么翻译吗?) 此方法已经过验证,用于药物放行检测和稳定性检测。
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