Toxicological overview of impurities in pharmaceutical products

被引：93

作者：

Jacobson-Kram, David ^{[1
]}

McGovern, Timothy ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Div Pulm & Allergy Prod, Silver Spring, MD 20993 USA

来源：

ADVANCED DRUG DELIVERY REVIEWS | 2007年 / 59卷 / 01期

关键词：

toxicology; pharmaceutical impurities; European medicines agency (EMEA); genotoxic impurities;

D O I：

10.1016/j.addr.2006.10.007

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：38 / 42

页数：5

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