Citation

Singh VK, Newman VL, Romaine PL, Hauer-Jensen M, Pollard HB. Expert Rev. Mol. Diagn. 2015; 16(1): 65-81.

Affiliation

a F. Edward Hébert School of Medicine "America's Medical School" .

Copyright

(Copyright © 2015, Future Drugs)

DOI

10.1586/14737159.2016.1121102

PMID

26568096

Abstract

Several candidate drugs for Acute Radiation Syndrome have been identified which have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule that underlies the Food and Drug Administration approval pathway requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy.

Language: en