Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval

被引：46

作者：

Peck, CC

Rubin, DB

Sheiner, LB

机构：

[1] Univ Calif San Francisco, Sch Med, Dept Lab Med, San Francisco, CA 94143 USA

[2] Univ Calif San Francisco, Sch Med, Dept Biopharmaceut Sci, San Francisco, CA 94143 USA

[3] Univ Calif San Francisco, Sch Pharm, Dept Lab Med, San Francisco, CA 94143 USA

[4] Georgetown Univ, Sch Med, Ctr Drug Dev Sci, Off Associate Dean Clin Res, Washington, DC USA

[5] Harvard Univ, Dept Stat, Cambridge, MA 02138 USA

[6] Univ Calif San Francisco, Sch Pharm, Dept Biopharmaceut Sci, San Francisco, CA 94143 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2003年 / 73卷 / 06期

关键词：

D O I：

10.1016/S0009-9236(03)00018-3

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：481 / 490

页数：10

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