20141022 ECA新闻：USP对药典方法验证的新要求

巴西木

GMP News
22/10/2014

USP's New Requirements for Compendial Validation

USP对药典方法验证的新要求

An interesting article from the USP on the future requirements for compendial validation has been published in the Pharmacopoeial Forum 39(6).

药典论坛39（6）公布了USP对药典方法验证的新要求。

This is the first General Chapter in a series of chapters which should introduce significant changes in the approaches to validation and its influences on compendial procedures.

这是一系列章节中的第一个凡例章节，将引入对验证方法的巨大变更，以及对药典方法的影响。

This new chapter <1200> will concentrate on the types of data expected by the USP to see if an analytical method can be accepted before it is included in USP/NF. Methods containing the data expected in the future will be suitable for compendial applications.

该新章节为<1200>，其中将主要关注USP所希望看到的数据类型，在被收入USP/NF之前检查分析方法是否能被接受。将来，申请收入药典的方法将需要包括这些数据。

According to USP's "General Notices" 6.30, alternative procedures may be used as long as they have been validated or have been demonstrated to be equivalent to or better than the existing compendial procedure.

根据USP凡例6.30，只要方法经过验证或被证明与已有的药典方法相等同或更优，则可以用该方法替代药典方法。

The article lists the different parameters for compendial validation. Concrete propositions are made. Five standardised studies may be used to evaluate the acceptability of a new procedure:

文章列出了药典方法验证的各种参数，并进行了分类。5个标准化研究可以用于评估新方法的可接受度：

• Specificity 专属性
• Accuracy 准确度
• Precision 精密度
• Range 范围
• Detectability 检测性能
  

The USP wishes to get feedback to the propositions made in this article.

USP希望收到对该文章的反馈。

You can find all information on the USP website of the Pharmacopeial Forum (PF).

在USP网站药典论坛上可以找到所有信息。

可以作药

根据USP凡例6.30，只要方法经过验证或被证明与已有的药典方法相等同或更优，则可以用该方法替代药典方法。

无言以对{:soso_e127:}

一沙一叶

这个介绍很简单。   

lumang

这个与药典的方法学确认是一回事吗？

biwt

介绍太简单了  

zhuliu2007

打不开上面提的那个链接