TGN1412: time to change the paradigm for the testing of new pharmaceuticals
By Bhogal, N. - Combes, R.
| Record number: | 2928660 |
|---|---|
| Category: | drug toxicity - monoclonal antibodies - human health and safety - anti-inflammatory activity - rheumatoid arthritis - epitopes - T-lymphocytes - adverse effects - sequence alignment - amino acid sequences - interleukin-6 - in vitro studies - iatrogenic disorders - species differences - animal use alternatives |
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.
Issued: May 2006
Journal Title: Alternatives to laboratory animals
ISSN: 0261-1929
Volume issue: 34 v. 2 no.
Pages: 225 - 239
AGRICOLA identifier: IND43842131
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