title: Pharmacological mechanism-based drug safety assessment and prediction.
abstract: Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.
authors.affiliation: Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Darrell.abernethy@fda.hhs.gov
authors.forename: D R
authors.initials: DR
authors.lastname: Abernethy
authors.forename: J
authors.initials: J
authors.lastname: Woodcock
authors.forename: L J
authors.initials: LJ
authors.lastname: Lesko
mesh_terms: D000818:Animals; D004345:Drug Industry / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D005544:Forecasting; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*