Hepatotoxicity associated with drugs,herbal medications and other complementary or alternative therapies has been a global concern for safety professionals and regulatory authorities.Instant identification of liver injury remains a challenge during both clinical development and in the post-marketing period.Advances have been made in the criteria used to identify cases of hepatotoxicity that are most likely to progress to liver failure or death.In addition,new methods are available to estimate the magnitude of hepatocyte loss associated with liver injury.This paper reviews these new methodologies and their applications to the ongoing monitoring and evaluation of product-related hepatoxicity.
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