title: Systems pharmacology to predict drug safety in drug development.
abstract: Ensuring that drugs are safe and effective is a very high priority for drug development and the US Food and Drug Administration review process. This is especially true today because of faster approval times and smaller clinical trials, especially in oncology and rare diseases. In light of these trends, systems pharmacology is seen as an essential strategy to understand and predict adverse drug events during drug development by analyzing interactions between drugs and multiple targets rather than the traditional "one-drug-one-target" approach. This commentary offers an overview of the current trends and challenges of using systems pharmacology to reduce the risks of unintended adverse events.
authors.affiliation: Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Lake Nona, Orlando, FL, USA. Electronic address: mtrame@cop.ufl.edu.
authors.forename: Mirjam N
authors.initials: MN
authors.lastname: Trame
authors.affiliation: Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Lake Nona, Orlando, FL, USA.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Biliouris
authors.affiliation: Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Lake Nona, Orlando, FL, USA.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Lesko
authors.affiliation: AstraZeneca, Drug Safety and Metabolism, Waltham, MA, USA.
authors.forename: Jerome T
authors.initials: JT
authors.lastname: Mettetal
mesh_terms: D000818:Animals; D055808:Drug Discovery / Q000379:methods / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D005544:Forecasting; D006801:Humans; D010601:Pharmacology, Clinical / Q000379:methods / Q000639:trends*; D049490:Systems Biology / Q000379:methods / Q000639:trends*
keywords: Adverse drug events; Drug development; Drug safety; Systems pharmacology