title: Systems approaches in risk assessment.
abstract: Adverse drug events (ADEs) remain a universal problem in drug development, regulatory review, and clinical practice with a substantial financial burden on the global health-care system. Recent advances in molecular and "omics" technologies, along with online databases and bioinformatics, have enabled a more integrative approach to understanding drug-target (protein) interactions, both desirable and undesirable, within a biological system. This has led to the development of systems approaches to risk assessment in an attempt to complement and improve on contemporary observational and predictive strategies for assessing risk. Although still in an evolutionary phase, systems approaches have the potential to markedly advance our understanding of ADEs and ability to predict them. Systems approaches will also move personalized medicine forward by enabling better identification of individual and subgroup risk factors.
authors.affiliation: Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida at Lake Nona, Orlando, Florida, USA. llesko@cop.ufl.edu
authors.forename: L J
authors.initials: LJ
authors.lastname: Lesko
authors.forename: S
authors.initials: S
authors.lastname: Zheng
authors.forename: S
authors.initials: S
authors.lastname: Schmidt
mesh_terms: D000818:Animals; D019295:Computational Biology / Q000379:methods*; D003695:Delivery of Health Care / Q000191:economics; D015195:Drug Design; D064420:Drug-Related Side Effects and Adverse Reactions; D017048:Health Care Costs; D006801:Humans; D058990:Molecular Targeted Therapy; D057285:Precision Medicine / Q000379:methods; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors