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【原创】一段话有奖翻译（genotoxic impurities）

影子

2011/06/15

希望各位来签到的版友除了签到外积极参与有奖翻译，一句、两句或一段都行：

The toxicological assessment of genotoxic impurities and the determination of acceptable limits for such impurities in active substances is a difficult issue and not addressed in sufficient detail in the existing ICH Q3X guidances. The data set usually available for genotoxic impurities is quite variable and is the main factor that dictates the process used for the assessment of acceptable limits. In the absence of data usually needed for the application of one of the established risk assessment methods, i.e. data from carcinogenicity long-term studies or data providing evidence for a threshold mechanism of genotoxicity, implementation of a generally applicable approach as defined by the Threshold of Toxicological Concern (TTC) is proposed. A TTC value of 1.5 μg/day intake of a genotoxic impurity is considered to be associated with an acceptable risk (excess cancer risk of <1 in 100,000 over a lifetime) for most pharmaceuticals. From this threshold value, a permitted level in the active substance can be calculated based on the expected daily dose. Higher limits may be justified under certain conditions such as short-term exposure periods.

相关话题

天晴了

第1楼2011/06/16

The toxicological assessment of genotoxic impurities and the determination of acceptable limits for such impurities in active substances is a difficult issue and not addressed in sufficient detail in the existing ICH Q3X guidances. 对基因毒性杂质进行毒理学评价并确定其在原料药中的可接受限度是一个棘手的问题，现行的ICHQ3X指南对此没有足够详细的阐述。

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分
该帖子已被版主-影子加2积分，加2经验;加分理由:积极参与

天晴了

第2楼2011/06/16

通常得到的基因毒性杂质数据变化很大，是决定使用何种方法评价可接受限度的主要因素。

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wccd1

第3楼2011/06/30

TTC——毒性阀值之关系？

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天晴了

第4楼2011/07/01

TTC-"毒理学关注阈值"？
wccd1(wccd1) 发表:TTC——毒性阀值之关系？

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symmacros

第5楼2011/07/02

应助达人

“TTC-毒理学关注阈值”比较妥当。
天晴了(smileqing) 发表: TTC-"毒理学关注阈值"？

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