Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans

被引:8
作者
Choudary, J [1 ]
Contrera, JF [1 ]
DeFelice, A [1 ]
DeGeorge, JJ [1 ]
Farrelly, JG [1 ]
Fitzgerald, G [1 ]
Goheer, MA [1 ]
Jacobs, A [1 ]
Jordan, A [1 ]
Meyers, L [1 ]
Osterberg, R [1 ]
Resnick, C [1 ]
Sun, CJ [1 ]
Temple, RJ [1 ]
机构
[1] US FDA,CTR DRUG EVALUAT & RES,ROCKVILLE,MD 20857
关键词
D O I
10.1016/S0009-9236(96)80003-8
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:265 / 267
页数:3
相关论文
共 2 条
[1]  
*FDA, IN PRESS FED REG
[2]   Are single-dose toxicology studies in animals adequate to support single doses of a new drug in humans? [J].
Monro, A ;
Mehta, D .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1996, 59 (03) :258-264