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Biotech / Medical : AtheroGenics, Inc.{AGIX}-nasdaq
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To: Clarksterh who wrote (306)10/25/2007 11:28:43 AM
From: keokalani'nui  Read Replies (1) of 332
 
Draft Guidance for Industry on Drug Induced Liver Injury:

fda.gov

Excerpt:

In general, the type of liver injury that leads to severe DILI is a predominantly hepatocellular injury. Hepatocellular injury is indicated by rises in serum AT activities reflecting release of alanine or aspartate aminotransferase (ALT or AST) from injured liver cells. The ability to cause some hepatocellular injury, however, is not a reliable predictor of a drug’s potential for severe DILI. Many drugs that cause transient rises in serum AT activity do not cause progressive or severe DILI, even if drug administration is continued. It is only those drugs that cause hepatocellular injury extensive enough to affect the liver’s functional ability to clear bilirubin from the plasma or to synthesize prothrombin and other coagulation factors that cause severe DILI. It is important to identify those drugs as rapidly as possible.
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