Regulatory acceptance of toxicogenomics data.

Abstract

Early identification of toxicologic side effects of a drug candidate is critical to an efficient drug discovery and development process. Toxicogenomics, the marriage of data-rich genomics approaches with traditional toxicologic end point evaluation combined with increasingly powerful in silico modeling approaches, promises to accelerate this process. The advent of parallel experimental platforms, for example, DNA microarrays, has enabled us to gain insight into complex biologic responses to drugs. The challenge is to analyze and correctly interpret these large data sets. Currently, no common standards exist for such data even though attempts are being made to streamline and standardize the presentation of the information. These efforts include ArrayExpress infrastructure for microarray data (http://www.ebi.ac.uk/arrayexpress), Minimum Information About a Microarray Experiment (http://www.mged. org/Workgroups/MIAME/miame.html), and MicroArray Gene Expression (MAGE) markup language (http://www.mged.org; http://www.omg.org/technology/documents/formal/gene_ expression.htm).