INTRAVASCULAR IOTROLAN IN THE US - WORK-IN-PROGRESS

被引：0

作者：

GOLDSTEIN, HA

JACOB, G

机构：

[1] Berlex Laboratories Inc, Wayne, New Jersey, 07470-7358

来源：

EUROPEAN RADIOLOGY | 1995年 / 5卷

关键词：

IOTROLAN; IOPAMIDOL; IOHEXOL; CONTRAST AGENTS;

D O I：

10.1007/BF02343270

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

The ongoing clinical development of iotrolan 280 mgI/ml for intravascular indications in the United States includes computed tomography, excretory urography, cerebral arteriography, aortography/visceral angiography, and peripheral arteriography. The safety, efficacy and patient tolerance of iotrolan has been assessed in two phase I and ten phase II and III multicenter, randomized, double-blind trials involving over 500 patients and volunteers. Each indication has been studied in two double-blind trials. It is anticipated that once these trials are complete, the data will permit a New Drug Application to be submitted to the US Food Drug Administration.

引用

页码：S93 / S95

页数：3