ABSTRACT

Transcriptional profi ling, in particular, has emerged as a desirable approach to be integrated into the list of safety testing strategies established in the drug development process ( 1 ). The biggest impact of microarray-based gene expression profi ling is in the early evaluation of a drug’s toxic potential at the discovery/development interface. Information gained from these predictive (or preliminary) toxicity studies is being used to select and to prioritize compounds entering the development process that stand the best chance of success. In addition, gene expression profi ling information can be used to help develop hypotheses on specifi c toxicity issues so that they can be addressed in a risk assessment.