主题:【求助】帮忙看一下一下三句话如何是什么意思?

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qingtian1210
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1. The release rates for *** tablets from the primary and
site qualification batches are provided below to demonstrate batch-to-batch consistency.

是否可以这样理解:如下图所示,初步稳定性批次和生产地点合格批次的***片剂的释药率存在批次间一致性。

2.
The amount of metabolite formed in rat and mouse was well in excess (30X) of the worse case human exposure of the impurity at NMT 2.5%. The metabolite exposure in the carcinogenicity studies was also in excess (~5X) of the worse case exposure to humans of the impurity at NMT 2.5%. The impurity was observed at exposure multiples with no unanticipated findings in the three species.

在网上查到NMT是not more than的缩写,是杂质限度。但搞不懂the worse case human exposure of the impurity和exposure multiples 的意思。

第一句是不是说:当暴露于杂质限度为2.5%的药品时,大鼠和小鼠体内形成的代谢产物量是人体内形成的代谢产物量的30倍。

第三句是不是说:三个物种对杂质的暴露量呈倍比关系,但结果均在预期范围内。

3. All primary stability batches were manufactured at approximately 130% of 115 kg commercial scale using three different batches of drug substance.
这句中的at approximately 130% of 115 kg commercial scale 该如何理解?
该帖子作者被版主 何当奇5积分, 2经验,加分理由:有效求助
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何当奇
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原文由 qingtian1210 发表:
1. The release rates for *** tablets from the primary and
site qualification batches are provided below to demonstrate batch-to-batch consistency.

是否可以这样理解:如下图所示,初步稳定性批次和生产地点合格批次的***片剂的释药率存在批次间一致性。
下面提供了主要和site qualification batches 的XXX片剂的释放率以验证批次间的连续性
没有做过医药,对这个site qualification batches是否应该是产地点合格批次。


何当奇
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2.
The amount of metabolite formed in rat and mouse was well in excess (30X) of the worse case human exposure of the impurity at NMT 2.5%. The metabolite exposure in the carcinogenicity studies was also in excess (~5X) of the worse case exposure to humans of the impurity at NMT 2.5%. The impurity was observed at exposure multiples with no unanticipated findings in the three species.

在网上查到NMT是not more than的缩写,是杂质限度。但搞不懂the worse case human exposure of the impurity和exposure multiples 的意思。

第一句是不是说:当暴露于杂质限度为2.5%的药品时,大鼠和小鼠体内形成的代谢产物量是人体内形成的代谢产物量的30倍。

第三句是不是说:三个物种对杂质的暴露量呈倍比关系,但结果均在预期范围内。

第三句我也是这么理解的。
前面,我就是不明第一句里面的那个well是什么意思?
the worese case human exposure of the impurity应该是人类对杂质最大曝露情形下,(这个中文组织还真是有点困难)
exposure multiples 应该是重复曝露的意思吧
何当奇
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3. All primary stability batches were manufactured at approximately 130% of 115 kg commercial scale using three different batches of drug substance.
这句中的at approximately 130% of 115 kg commercial scale 该如何理解?
是不是说115kg商品规格的130%?
那么应该是含量,质量?还是指标的130%?
医药还是跟农药有很大区别的
qingtian1210
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谢谢!我重新整理了一下,及时反馈我的想法。
1. The release rates for *** tablets from the primary and
site qualification batches are provided below to demonstrate batch-to-batch consistency.
下面提供了初步稳定性和场地合格证的XXX片剂的释放率以验证批次间的一致性。
2.The amount of metabolite formed in rat and mouse was well in excess (30X) of the worse case human exposure of the impurity at NMT 2.5%. The metabolite exposure in the carcinogenicity studies was also in excess (~5X) of the worse case exposure to humans of the impurity at NMT 2.5%. The impurity was observed at exposure multiples with no unanticipated findings in the three species.
最后一句话我觉得是:在反复曝露的情况下,在三个物种中,该杂质均未观察到预期的结果。
3.All primary stability batches were manufactured at approximately 130% of 115 kg commercial scale using three different batches of drug substance.
这句中的at approximately 130% of 115 kg commercial scale 该如何理解?
我觉得是说按照115kg的130%投料

剩余的我再琢磨琢磨!
何当奇
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原文由 qingtian1210 发表:
谢谢!我重新整理了一下,及时反馈我的想法。
1. The release rates for *** tablets from the primary and
site qualification batches are provided below to demonstrate batch-to-batch consistency.
下面提供了初步稳定性和场地合格证的XXX片剂的释放率以验证批次间的一致性。
2.The amount of metabolite formed in rat and mouse was well in excess (30X) of the worse case human exposure of the impurity at NMT 2.5%. The metabolite exposure in the carcinogenicity studies was also in excess (~5X) of the worse case exposure to humans of the impurity at NMT 2.5%. The impurity was observed at exposure multiples with no unanticipated findings in the three species.
最后一句话我觉得是:在反复曝露的情况下,在三个物种中,该杂质均未观察到预期的结果。
3.All primary stability batches were manufactured at approximately 130% of 115 kg commercial scale using three different batches of drug substance.
这句中的at approximately 130% of 115 kg commercial scale 该如何理解?
我觉得是说按照115kg的130%投料

剩余的我再琢磨琢磨!

就觉得那个物种有点奇怪,叫品种或者种类吧
happyjyl
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原文由 redanqi 发表:
原文由 qingtian1210 发表:
The impurity was observed at exposure multiples with no unanticipated findings in the three species.
最后一句话我觉得是:在反复曝露的情况下,在三个物种中,该杂质均未观察到预期的结果。

就觉得那个物种有点奇怪,叫品种或者种类吧


这里的three species应该是指试验中用到的三种实验动物吧。
poorlittle
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原文由 qingtian1210 发表:
The impurity was observed at exposure multiples with no unanticipated findings in the three species.
最后一句话我觉得是:在反复曝露的情况下,在三个物种中,该杂质均未观察到预期的结果。


with no unanticipated findings 不完全等于 with anticipated findings, 但译作“未观察到预期的结果”似不通。

试译:

该杂质均观察到(or 出现, or 均观察到该杂质), 并且没有(no)意料之外(unanticipated)的发现(findings)。

闲鹤野云
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原文由 happyjyl 发表:
原文由 redanqi 发表:
原文由 qingtian1210 发表:
The impurity was observed at exposure multiples with no unanticipated findings in the three species.
最后一句话我觉得是:在反复曝露的情况下,在三个物种中,该杂质均未观察到预期的结果。

就觉得那个物种有点奇怪,叫品种或者种类吧


这里的three species应该是指试验中用到的三种实验动物吧。

大鼠、小鼠和人,三种动物。
品种=breed, 品系=strain,种/物种=species, 种类=kind/category
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