Table 2.

Basic requirements of the FDA “Animal Rule” (Aebersold 2012)

“A reasonably well-understood pathophysiological mechanism of the toxicity of [radiation] and its prevention or substantial reduction by [mitigators]” “The effect is demonstrated in more than one animal species expected to react with a response predictive for humans…” “The animal study endpoint is clearly related to the desired benefit in humans, generally the enhancement of survival or prevention of major morbidity” The work is done according to “Good Laboratory Practices”