title: Comparing the Hematopoetic Syndrome Time Course in the NHP Animal Model to Radiation Accident Cases From the Database Search.
abstract: Since controlled clinical studies on drug administration for the acute radiation syndrome are lacking, clinical data of human radiation accident victims as well as experimental animal models are the main sources of information. This leads to the question of how to compare and link clinical observations collected after human radiation accidents with experimental observations in non-human primate (NHP) models. Using the example of granulocyte counts in the peripheral blood following radiation exposure, approaches for adaptation between NHP and patient databases on data comparison and transformation are introduced. As a substitute for studying the effects of administration of granulocyte-colony stimulating factor (G-CSF) in human clinical trials, the method of mathematical modeling is suggested using the example of G-CSF administration to NHP after total body irradiation.
authors.affiliation: *Bundeswehr Institute of Radiobiology affiliated to the University of Ulm, Munich, Germany; †University of Maryland, School of Medicine, Dept. of Radiation Oncology, Baltimore, MD; ‡U.S. Food and Drug Administration (FDA), Counter-Terrorism and Emergency Coordination Staff, FDA-CDER, 10001 New Hampshire Ave, Mail Stop 2163, Silver Spring, MD.
authors.forename: Dieter H
authors.initials: DH
authors.lastname: Graessle
authors.forename: Harald
authors.initials: H
authors.lastname: Dörr
authors.forename: Alexander
authors.initials: A
authors.lastname: Bennett
authors.forename: Alla
authors.initials: A
authors.lastname: Shapiro
authors.forename: Ann M
authors.initials: AM
authors.lastname: Farese
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: MacVittie
authors.forename: Viktor
authors.initials: V
authors.lastname: Meineke
mesh_terms: D054508:Acute Radiation Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology*; D000818:Animals; D016208:Databases, Factual; D004195:Disease Models, Animal; D004307:Dose-Response Relationship, Radiation; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D008253:Macaca mulatta; D008297:Male; D011829:Radiation Dosage; D011837:Radiation-Protective Agents / Q000627:therapeutic use; D018788:Radioactive Hazard Release; D013045:Species Specificity; D013997:Time Factors; D016896:Treatment Outcome; D014916:Whole-Body Irradiation / Q000009:adverse effects
chemical_list: D011837:Radiation-Protective Agents; D016179:Granulocyte Colony-Stimulating Factor