title: Ontology-based Vaccine and Drug Adverse Event Representation and Theory-guided Systematic Causal Network Analysis toward Integrative Pharmacovigilance Research.
abstract: Compared with controlled terminologies (e.g., MedDRA, CTCAE, and WHO-ART), the community-based Ontology of AEs (OAE) has many advantages in adverse event (AE) classifications. The OAE-derived Ontology of Vaccine AEs (OVAE) and Ontology of Drug Neuropathy AEs (ODNAE) serve as AE knowledge bases and support data integration and analysis. The Immune Response Gene Network Theory explains molecular mechanisms of vaccine-related AEs. The OneNet Theory of Life treats the whole process of a life of an organism as a single complex and dynamic network (i.e., OneNet). A new "OneNet effectiveness" tenet is proposed here to expand the OneNet theory. Derived from the OneNet theory, the author hypothesizes that one human uses one single genotype-rooted mechanism to respond to different vaccinations and drug treatments, and experimentally identified mechanisms are manifestations of the OneNet blueprint mechanism under specific conditions. The theories and ontologies interact together as semantic frameworks to support integrative pharmacovigilance research.
authors.affiliation: Unit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, MI 48109, USA. Department of Microbiology and Immunology, University of Michigan Medical School, Ann Arbor, MI 48109, USA. Center for Computational Medicine and Biology, University of Michigan Medical School, Ann Arbor, MI 48109, USA. Comprehensive Cancer Center, University of Michigan Medical School, Ann Arbor, MI 48109, USA.
authors.forename: Yongqun
authors.initials: Y
authors.lastname: He
keywords: Ontology of Adverse Events (OAE); Ontology of Drug Neuropathy Adverse Events (ODNAE); Ontology of Vaccine Adverse Events (OVAE); Pharmacovigilance; adverse event; bioinformatics; drug; the Immune Response Gene Network Theory; the OneNet Theory of Life; vaccine