The MCART consortium animal models series

Health Physics

Volumn 103, Issue 4, 2012, Pages 340-342

  MacVittie, Thomas J ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

accidents nuclear; exposure radiation; laboratory animals; model

Indexed keywords

RADIOISOTOPE;

ACUTE RADIATION SYNDROME; ANIMAL; HUMAN; METHODOLOGY; NUCLEAR ACCIDENT; PATHOPHYSIOLOGY; RADIATION INJURY; RADIATION PROTECTION; REVIEW;

ACUTE RADIATION SYNDROME; ANIMALS; HUMANS; RADIATION INJURIES, EXPERIMENTAL; RADIATION PROTECTION; RADIOACTIVE HAZARD RELEASE; RADIOISOTOPES;

ANIMALIA;

EID: 84866018294     PISSN: 00179078     EISSN: None     Source Type: Journal    
DOI: 10.1097/HP.0b013e318261175a     Document Type: Review

References (4)

1. Crawford LM. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. 21 CFR parts 314 and 601, FDA, HHS; ACTION: Final Rule. Ref Type: Bill/Resolution; Federal Register 67[105]:37988-37998; 2002.
2. Nightengale SL, Prasher JM, Simonson S. Emergency use authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerging Infectious Diseases 7(13):1046-1050; 2007.
3. U.S. Food and Drug Administration. Guidance for industry, animal models - essential elements to address efficacy under the Animal Rule. Rockville, MD: CDER and CBER; January 2009; 1-19. Available at http://www.fda.gov/cder/ guidance/index.htm.
4. Willliams JP, Brown SL, Georges GE, Hauer-Jensen M, Hill RP, Huser AK, Kirsch DG, MacVittie TJ, Mason KA, Medhora MM, Moulder JE, Okunieff P, Otterson MF, Robbins ME, Smathers JB, McBride WH. Animal models for medical countermeasures to radiation exposure. Radiat Res 173: 557-578; 2010.