title: Animal models for acute radiation syndrome drug discovery.
abstract: BACKGROUND
  Although significant scientific advances have been made over the past six decades in developing safe, nontoxic and effective radiation/medical countermeasures (MCMs) for acute radiation syndrome (ARS), no drug has been approved by the US FDA. The availability of adequate animal models is a prime requisite under the criteria established by the FDA 'animal rule' for the development of novel MCMs for ARS and the discovery of biomarkers for radiation exposure.
  
  
  METHODS
  This article reviews the developments of MCMs to combat ARS, with particular reference to the various animal models (rodents: mouse and rat; canine: beagle; minipigs and nonhuman primates [NHPs]) utilized for the in-depth evaluation. The objective, pathways and challenges of the FDA Animal Efficacy Rule are also discussed.
  
  
  CONCLUSIONS
  There are a number of well-defined animal models, the mouse, canine and NHP, that are being used for the development of MCMs. Additional animal models, such as the minipig, are under development to further assist in the identification, efficacy testing and approval of MCMs under the FDA Animal Efficacy Rule.
authors.affiliation: Uniformed Services University of the Health Sciences, F. Edward Hébert School of Medicine, Department of Radiation Biology , Bethesda, MD , USA.
authors.forename: Vijay K
authors.initials: VK
authors.lastname: Singh
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Newman
authors.forename: Allison N
authors.initials: AN
authors.lastname: Berg
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: MacVittie
mesh_terms: D054508:Acute Radiation Syndrome / Q000188:drug therapy*; D000818:Animals; D015415:Biomarkers / Q000378:metabolism; D004195:Disease Models, Animal; D004285:Dogs; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D051379:Mice; D011323:Primates; D051381:Rats; D013552:Swine; D013556:Swine, Miniature; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers
keywords: FDA Animal Efficacy Rule; animal model; canine; medical countermeasures; mice; minipig; nonhuman primate