THE PATH TO NEW FDA GUIDELINES FOR CLINICAL-EVALUATION OF ANTIINFECTIVE DRUGS

被引：0
|
作者：
GILBERT, DN
BEAM, TR
KUNIN, CM
机构：
[1] OREGON STATE UNIV,CORVALLIS,OR 97331
[2] VET ADM MED CTR,BUFFALO,NY 14215
[3] OHIO STATE UNIV,COLUMBUS,OH 43210
[4] SUNY BUFFALO,BUFFALO,NY 14260
来源：
REVIEWS OF INFECTIOUS DISEASES | 1991年 / 13卷
关键词：
D O I：
暂无
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed changes from draft documents. If approved and implemented, the envisioned changes should enable investigators and sponsors to improve the quality of clinical trials of anti-infective drugs. The ultimate goal is to provide physicians with the best information about new drugs and thus to enhance the care of patients with infectious diseases.
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页码：S890 / S894
页数：5
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