USP修订通则<1210>—程序验证的统计学工具

一沙一叶

药典论坛40（5）宣布正在修订USP通则<1210>—程序验证的统计学工具。这个新的章节可以看做是对<1225>—要点方法验证的补充。<1210>中的统计程序不仅适用于药典程序，也适用于分析方法的变更，包括API和大分子生物分子。这一章引入了数理统计方法，可以用于分析方法的验证。

In the Pharmacopoeial Forum 40(5) the In Process Revision of USP General Chapter <1210> - Statistical Tools for Procedure Validation has been announced. 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. This comprehensive chapter introduces statistical methods that can be used during the validation of analytical methods.
Specifically, this chapter covers the following analytical performance characteristics from a statistical point of view:
Accuracy
Precision
Range
Detection
limit Quantitation
limit Linearity
The USP proposal of the General Chapter <1210> - Statistical Tools for Procedure Validation is available in the Pharmacopoeial Forum.

lumang

有兴趣的，研究后给大家分享下，

实崇融

统计学在GMP管理中的作用越来越多。值得好好学习。