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Article

Title: SAFETY MARKERS: Toxicology's Holy Grail

Author: Mitchell, Pete; Branca, Malorye A Article Type: Product Analysis
Source: Pharma DD, v1 n1 p22(4) Publication Date: Jul 2006
  ISSN: 1932-1953
  Illustrations: Charts
URL of Publication: http://www.pharmadd.com

The pharmaceutical industry is pouring efforts to acquire safety biomarkers necessary to advance preclinical toxicology. The TeGenero trial has turned into a disaster when its monoclonal antibody tested on five volunteers resulted in serious organ failure. There are drugs that seem safe when tested on animals during pre-clinical stage but become toxic when tested on humans. The industry is attempting to address the problem by implementing three changes: technologies for biomarker discovery, mechanistic studies, and data collection. Tools for biomarking include high content analysis, microscopic imaging of histological changes, proteomics, metabonomics and toxicgenomics. Abbott has conducted a toxicogenomic study to determine the best alternative when lead content in a series shows cardiotoxicity in the rat. Pathways analysis, a method to study the mechanism of toxicity, explains that some genes are activated in one animal but downregulated in another. Ingenuity and GlaxoSmithKline have used this approach. Data mining and collection are important in safety biomarking since processing a huge amount of samples allows prediction of a certain toxicity. The Federal Drug Authority and The Critical Path Institute have encouraged formation initiatives targeting the discovery of safety biomarkers for the entire industry to share. One of these organizations is the Predictive Safety Testing participated in by companies such as Bristol-Myers Squib, Johnson & Johnson and Novartis.

Special Features: Charts

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Biomarkers Toxicology

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