Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans

被引：28

作者：

Lesko, LJ

Rowland, M

Peck, CC

Blaschke, TF

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol & Biopharmaceut, Rockville, MD 20851 USA

[2] Univ Manchester, Sch Pharm & Pharmaceut Sci, Manchester, Lancs, England

[3] Georgetown Univ, Ctr Drug Dev Sci, Washington, DC 20057 USA

[4] Stanford Univ, Sch Med, Dept Med, Div Clin Pharmacol, Stanford, CA 94305 USA

来源：

JOURNAL OF CLINICAL PHARMACOLOGY | 2000年 / 40卷 / 08期

关键词：

D O I：

10.1177/00912700022009530

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Two international meetings were convened in 1998 to review the current science of drug development and the potential opportunities to optimize the evaluation of new drugs in humans. This report represents a synopsis of these meetings, and focuses on the current state of knowledge pertaining to drug development, future scientific and technical needs, and the relative merits of various strategies intended to accelerate the clinical development of drugs. (C) 2000 the American College of Clinical pharmacology.

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页码：803 / 814

页数：12

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