The use of toxicogenomic data in risk assessment: A regulatory perspective

Recent advances in genomic research have provided new insights into mechanisms of toxicity evoked by drugs or xenobiotics. Several governmental and commercial organizations are at present actively building up databases containing large amounts of toxicogenomics information. With promises to improve our ability to characterize hazard, scientists are facing the challenge as to how to link patterns of gene expression and gene clustering to specific adverse effects of toxicants or classes of toxicants. The future of toxicogenomics lies in the robustness of the databases generated. Regulators are working together with institutes and industry in exploring the potential use of these databases in regulatory purposes. It is, however, anticipated that regulatory use of the toxicogenomic databases as supportive information in the assessment procedure of new drug applications will be on a case-by-case basis until the predictive value of the databases is firmly established.