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ABI and FDA Collaborate to Study Molecular Basis of Liver Toxicity of Diabetes Drugs

This article has been corrected to address an error in the last paragraph that stated that the FDA ordered the withdraw of Vioxx after safety concerns. The drug was voluntarily withdrawn.

 

NEW YORK, March 9 (GenomeWeb News) - Applied Biosystems is collaborating with the Food and Drug Administration to study the molecular basis of liver toxicity of diabetes drugs, ABI said today.

 

Working with the FDA's NationalCenterfor Toxicological Research, ABI scientists have been using the company's Expression Array system and Rat Genome Survey microarrays to study potential liver toxicity of a common class of diabetes drugs. Samples are provided by the FDA/NCTR.

 

Further, ABI will use its real-time PCR systems and TaqMan Gene Expression assays to validate the results and extend the study of biomarkers found to other samples. The aim is to identify specific genes and pathways associated with liver toxicity and predict toxicity of future drugs in the same chemical class.

 

The collaboration follows the recent formation of a Drug Safety Oversight Board by the FDA after the withdrawal of Vioxx and Tysabri over safety concerns.

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