TGN1412: Time to change the paradigm for the testing of new pharmaceuticals

被引：33

作者：

Bhogal, Nirmala ^{[1
]}

Combes, Robert ^{[1
]}

机构：

[1] FRAME, Nottingham NG1 4EE, England

来源：

ATLA-ALTERNATIVES TO LABORATORY ANIMALS | 2006年 / 34卷 / 02期

关键词：

animal; clinical trial; in vitro; preclinical; study design; TGN1412;

D O I：

10.1177/026119290603400204

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Clinical studies in human volunteers are an essential part of drug development. These studies are designed to account for possible differences between the effects of pharmaceutical products in preclinical studies and in humans. However, the tragic outcome of the recent Phase 1 clinical trial on TGN1412 casts considerable doubt over the relevance of this traditional drug development paradigm to the testing of therapeutic agents for human use. The role of alternatives to animal testing is considered, and a series of recommendations are made, which could ensure that clinical trials are well informed and based on the most relevant scientific information.

引用

页码：225 / 239

页数：15

共 38 条

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