Guidelines from the International Conference on Harmonisation (ICH)

被引：229

作者：

Branch, SK ^{[1
]}

机构：

[1] MHRA, London SW8 5NQ, England

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2005年 / 38卷 / 05期

关键词：

International Conference on Harmonisation; NMR spectroscopy; specifications; analytical validation; impurities stability;

D O I：

10.1016/j.jpba.2005.02.037

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

This article describes the development of international guidance on registration of technical dossiers supporting applications to market medicinal products. Aspects of guidance of particular relevance to the use of NMR spectroscopy in drug development and control are discussed. (c) 2005 Published by Elsevier B.V.

引用

页码：798 / 805

页数：8