Safety of biotechnological products

被引：1

作者：

Bass, R ^{[1
]}

Purves, J ^{[1
]}

Amati, MP ^{[1
]}

机构：

[1] European Med Evaluat Agcy, Unit Evaluat Med Prod Human Use, London E14 4HB, England

来源：

PHARMACOLOGY & TOXICOLOGY | 2000年 / 86卷

关键词：

D O I：

10.1034/j.1600-0773.2000.d01-8.x

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The safety of biotechnological products used for medicinal products is addressed by EU council directives. The general principles and the regulatory framework for the handling of new drug applications within this areas are described both with respect to benefit/risk evaluation, quality assessment, preclinical safety and efficacy testing.

引用

页码：27 / 29

页数：3