Determination of the Liver Toxicity of an Agent

A method of aiding in predicting the effect of an agent on liver function in a subject, comprising:

• administering a test agent to a subject;
• measuring the level(s) of one or more biomarkers selected from the biomarkers listed in Tables 1, 2, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 in a biological sample obtained from the subject;
• and
• comparing the level(s) of the one or more biomarkers in the sample(s) to hepatoxicity-positive and/or hepatoxicity-negative reference levels of the one or more biomarkers in order to predict the effect of the test agent on liver function in the subject.

A method of determining whether an agent is a hepatotoxicant, comprising:

• (a) incubating a first hepatocyte culture in the presence of a test agent;
• (b) incubating a second hepatocyte culture in the absence of the test agent;
• (c) measuring the level(s) of one or more biomarker(s) selected from the group of biomarkers listed in Tables 1, 2, and 18 in the first and second hepatocyte cultures;
• and
• (d) comparing the level(s) of the one or more biomarker(s) obtained in the first hepatocyte culture to the level(s) of the one or more biomarkers obtained in the second hepatocyte culture, wherein differential level(s) of the one or more biomarker(s) in the first hepatocyte culture as compared to the level(s) in the second hepatocyte culture is indicative of the test agent being a hepatotoxicant.