Application of Serum Chemistry Markers

The traditional approach for assessing hepatotoxicity integrates clinical chemistry markers, histopathology evaluation, cytochrome P450 enzyme induction, in-life 

Evidence that a drug causes hepatocellular injury, as shown by a serum ALT 3 x the upper limit of normal (ULN). 

Evidence of increased serum total bilirubin ( 2x ULN) with no evidence of intra- or extra-hepatic bilirubin obstruction (elevated serum ALP) or Gilberts syndrome. 

No evidence of another cause of hepatocellular injury, such as viral hepatitis, marked hypotension, or congestive heart failure. 

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