鑫达医学翻译公司-最好的医学翻译、病历翻译、药学翻译、sci论文翻译、生物翻译网站!您最好的医学论文翻译合作伙伴!
设为首页 | 加入收藏 | 联系我们
首页 > 翻译讲堂 >

药学翻译-作品展示

发布者:鑫达医学翻译公司 发布时间:2011-05-03阅读:

原文
Question 2. The guideline indicates that it is necessary to reduce a known or suspected mutagenic impurity to as low as reasonably practicable (ALARP) even if the level is below the threshold of toxicological concern (TTC), i.e. in the decision tree ALARP considerations precede TTC considerations. If the level is already known to be below the TTC (which is a very conservative value), why is it necessary to reduce it even further? On a practical basis this would often involve developing analytical methods that have limits of quantitation around or below 1ppm level. The effort and resource this can take, and the possibility that it is not actually achievable, does not seem commensurate with the perceived risk.
If the level of a mutagenic impurity is below the threshold of toxicological concern (equivalent to a clinical dose ≤1.5 μg/day) it is not necessary to apply ALARP considerations unless it is a structure of very high concern, e.g. N-nitroso, aflatoxins-like and azoxy-compounds.

译文
问题2
该指南指出:即使按决策树程序其水平低于毒理学关注阈值(TTC),也要尽可能地减少已知或未知的诱变杂质。也就是决策树中所述优先考虑ALARP,再考虑TTC。既然已知杂质含量低于TTC(一个极为保守的数值),为何还要考虑进一步降低呢?实际上这还涉及定量限在1ppm左右的分析方法。其所需操作、所用资源以及最终不可实现的可能性与其风险并不相对应。
回答
若诱变杂质水平低于毒理学关注阈值(相当于≤1.5 μg/天的临床剂量),除非为高风险结构,如N-亚硝基、黄曲霉毒素类与氧化偶氮化合物,否则没有必要应用ALARP原则。
 


鑫达医学翻译公司本着“专业、专注、诚信、共赢”的原则,旨在为广大客户提供生物学、医学、药学材料的口译与笔译,业务范围为医学英语翻译病历翻译医学文献翻译药学翻译SCI医学论文翻译以及写作与投稿,宣传册制作,项目申报材料及医疗类中英文网站的建设工作。
联系方式

免费咨询电话:400-6870-112
传真:0531-88956115
地址:山东省济南市高新区舜华路2000号舜泰广场6号楼27层CD区
邮箱: trans@xdtrans.com