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Regulatory science update: FDA and International Serious Adverse Events Consortium complete third data release.

Chemical Business Newsbase

| February 19, 2010 | COPYRIGHT 2000 Elsevier Engineering Information, Inc. (Hide copyright information)Copyright

The US Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs). The data focus on the genetics associated with DILI and SSR and may help researchers to better predict an individual's risk of developing these serious complications. Drug induced liver injury occurs in a small subset of patients and is often associated with a drug that is an unpredictable liver toxin, and may be the cause of acute liver failure in some patients. Drug-induced SSRs, such …

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