STATUS OF SAFETY PHARMACOLOGY IN THE PHARMACEUTICAL-INDUSTRY, 1993

被引：16

作者：

KINTER, LB ^{[1
]}

GOSSETT, KA ^{[1
]}

KERNS, WD ^{[1
]}

机构：

[1] SMITHKLINE BEECHAM PHARMACEUT,DEPT TOXICOL US,KING OF PRUSSIA,PA

来源：

DRUG DEVELOPMENT RESEARCH | 1994年 / 32卷 / 04期

关键词：

PHARMACOLOGY; TOXICOLOGY; SAFETY ASSESSMENT; CLINICAL PHARMACOLOGY; ANIMALS;

D O I：

10.1002/ddr.430320404

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

General pharmacology and safety pharmacology studies are of considerable value in drug discovery and safety assessment. The knowledge gained from these studies adds mechanistic perspectives and functional dimensions to contemporary animal pharmacology and toxicology studies. If conducted prior to initiation of drug development activities, general pharmacology and safety pharmacology studies can assist in the selection of drug classes and specific candidates for drug development, and contribute to selection of rational high doses for chronic toxicity studies. If conducted prior to initiation of clinical safety studies, these studies can influence the design of clinical protocols so that appropriate strategies are put in place to ensure appropriate patient management and care. Finally, general pharmacology and safety pharmacology studies can provide an important communication pathway between the non-clinical and clinical segments of a drug development program. (C) 1994 Wiley-Liss, Inc.

引用

页码：208 / 216

页数：9