it was suggested that a level of transcriptional change greater than 3 percent indicates drug-related pathology. Information gained from studying gene expression changes can be used to

  • identify toxicological issues early prior to large financial investments;

  • select the compounds that are least likely to fail because of toxicological issues;

  • understand mechanisms of toxicity; and

  • bridge preclinical and clinical data by understanding the mechanisms and commonalities in responses.

These gene expression assays, however, apply only to rat models, and the next challenge is to transition from prediction of toxicity in rats to prediction of toxicity in humans.

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