新人求助 元素杂质风险评估

我天呐

我看了ICH Q3D的PDE限度，但是看了其他好多评估都是30%的PDE限度作为控制阈值，这个30%是怎么来的呢？有法规要求吗


补充内容 (2021-12-24 13:28):
好了好了，看到正版的了。自己下载的中文版只有10页，没看到相关内容，昨天才看了完整版

lisu247

很负责任的说，你没有认真细看Q3D
ICH Q3D 5.6 风险评估过程总结：
The risk assessment is summarized by reviewing relevant product or component specific data combined with information and knowledge gained across products or processes to identify the significant probable elemental impurities that may be observed in the drug product.
The summary should consider the significance of the observed or predicted level of the elemental impurity relative to the PDE of the elemental impurity. As a measure of the significance of the observed elemental impurity level, a control threshold is defined as a level that is 30% of the established PDE in the drug product. The control threshold may be used to determine if additional controls may be required.If the total elemental impurity level from all sources in the drug product is expected to be consistently less than 30% of the PDE, then additional controls are not required, provided the applicant has appropriately assessed the data and demonstrated adequate controls on elemental impurities.
风险评估的总结是通过综合相关药品或组分的特定数据，并结合从药品或制备工艺中获得的信息和认知，用以识别在药品中很可能观察到的元素杂质。
总结中应考虑实测的或预测的元素杂质水平相对于其PDE 值的显著性。将药品既定 PDE 值的 30%定义为控制阈值，作为实测元素杂质水平显著性的衡量指标。控制阈值可用于判断是否需要额外的控制。
如果药品中所有来源的总元素杂质水平始终低于 PDE的 30%，只要申请人对数据进行了适当的评估并证明已对元素杂质进行了足够的控制，则不再需要额外的控制。

一路向西

https://www.cde.org.cn/ichWeb/guideIch/toGuideIch/1/0
下载下来多看几遍吧。

我天呐

lisu247 发表于 2021-12-23 14:12
很负责任的说，你没有认真细看Q3D
ICH Q3D 5.6 风险评估过程总结：
The risk assessment is summarized b ...

谢谢谢谢，是我电脑里下载的版本有问题，一共只有10页，确实没有相关内容，昨天找到官网之后才看到。

小金库

感谢楼主的分享,学习一下