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。
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!
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。
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。