Application of toxicogenomic tools in the drug research and development process.

The cost for the development of new active and safe drugs is higher than ever and continues to increase. At the same time, both the pharmaceutical industry and the Regulatory Authorities are, despite the increasing effort to develop safer drugs, concerned by the risk of unexpected side effects observed in the late steps of the development of new drugs, either in late clinical development or after marketing approval. Then, the early knowledge of any potential toxic effect of a new drug is a key issue to allow adequate decision making.

A new human hepatoma cell line to study repeated cell toxicity.

Early toxicity screening of new drugs is performed to select candidates for development. Many cell models are used to assess basic cytotoxicity and to show a good correlation with acute toxicity. However, their correlation with chronic in vivo exposure is inadequate.