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U.S. Department of Health and Human Services

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FDA-Entelos, Inc. Drug-Induced Liver Injury (DILI) Program

Drug-induced liver injury (DILI) is one of the most common reasons for regulatory actions concerning drugs in development and for withdrawal of drugs from marketing and use in clinical practice. Worldwide, the estimated global annual incidence rate of DILI is 13.9-24.0 per 100,000 inhabitants, and DILI accounts for an estimated 3%-9% of all adverse drug reactions reported to health authorities.  In August 2007, FDA entered into a Cooperative Research and Development Agreement (CRADA) with Entelos, Inc. to collaborate on the development of a computer model to predict Drug-Induced Liver Injury (DILI).  Under the terms of the CRADA, Entelos and FDA are working together with leading academic researchers and pharmaceutical companies to work toward a “virtual patient” computer model simulation to predict whether new drugs will produce DILI.  In addition to the CRADA, FDA issued a contract with Entelos, Inc in September 2008 to perform an exhaustive review of the scientific literature and produce the first implementation step of the computer model, describing the currently known and hypothesized mechanisms for DILI.

For more information about the FDA-Entelos DILI Program visit the Drug-Induced Liver Injury description on FedBizOpps.gov.