20150319 ECA新闻：USP新通论<1210>方法验证统计工具

20150319 ECA新闻：USP新通论<1210>方法验证统计工具  

2015-03-26 23:49:53|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015226114953362/

GMP News
18/03/2015

New General USP Chapter <1210> on Statistical Tools for Procedure Validation

USP新通论<1210>方法验证统计工具

In the Pharmacopoeial Forum 40(5) the In Process Revision of USP General Chapter <1210> - Statistical Tools for Procedure Validation has been announced.

在药典论坛40（5）里，修订中的USP通论<1210>方法验证统计工具已经公布。

This new chapter is seen as a complement to the chapter <1225> - Pharmacopoeial methods validation. The statistical procedures which are presented in <1210> are not only applicable for Pharmacopoeial procedures but for a variety of analytical methods, both for chemical def. APIs as well as for large biological molecules.

该新章节看起来是对<1225>药典方法验证的补充。在<1210>里给出的统计程序不仅适用于药典方法，也适用于不同的分析方法，不管是化学合成原料药还是生物大分子。

This comprehensive chapter introduces statistical methods that can be used during the validation of analytical methods. An analytical procedure is considered validated if it is shown that the performance characteristics are within required limits with stated confidence.

该综合性章节引入了统计方法，可以在分析方法验证中使用。一份分析方法的性能特性如果在验证中在声明的置信度里符合要求的限度，则被认为是经过验证的。

Specifically, this chapter covers the following analytical performance characteristics from a statistical point of view:

该章节包括了从统计学角度来看的以下分析性能特性

• Accuracy
• Precision
• Range
• Detection limit
• Quantitation limit
• Linearity
• 准确度
• 精密度
• 范围
• 检测限
• 定量限
• 线性
  

The USP proposal of the General Chapter <1210> - Statistical Tools for Procedure Validation is available in the Pharmacopoeial Forum

USP的通论<1210>方法统计学工具在药典论坛上可以找到。

Source: USP