NONCLINICAL TOXICITY STUDIES OF ANTIVIRAL DRUGS INDICATED FOR THE TREATMENT OF NON-LIFE-THREATENING DISEASES - EVALUATION OF DRUG TOXICITY PRIOR TO PHASE-1 CLINICAL-STUDIES

被引：8

作者：

HOYLE, PC ^{[1
]}

COOPER, EC ^{[1
]}

机构：

[1] US FDA,CTR DRUG EVALUAT & RES,DIV ANTIVIRAL DRUG PROD,ROCKVILLE,MD 20875

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 1990年 / 11卷 / 01期

关键词：

D O I：

10.1016/0273-2300(90)90009-Z

中图分类号：

DF [法律]; D9 [法律]; R [医药、卫生];

学科分类号：

0301 ; 10 ;

摘要：

The types of nonclinical toxicity studies conducted during the preclinical research and development of antiviral drugs intended for the treatment of non-life-threatening diseases in humans are reviewed. This guidance also applies to other classes of drugs under development for nonlife-threatening diseases that fall under the regulatory responsibility of the Food and Drug Administration's Division of Antiviral Drug Products, including systemic antifungals, antimycobacterials, and immunomodulators. © 1990.

引用

页码：81 / 89

页数：9