A Trans-Agency Workshop on the Pathophysiology of Radiation-Induced Lung Injury.

ABSTRACT: As of January 2021, the U.S. Food and Drug Administration has approved four radiation exposure medical countermeasures (MCMs) to treat hematological acute effects, but no MCM is yet approved for radiation-induced lung injury (RILI). MCM approval for RILI and other subsyndromes utilizes the FDA Animal Efficacy Rule (Animal Rule), that requires demonstration of MCM efficacy in animal models with well-characterized pathophysiology, therefore, allowing translation to human use. A good animal model replicates the clinical condition and natural history of the disease, while allowing for studying the mechanism of action of the applied MCM and exhibiting clear benefits in terms of primary and secondary endpoints. However, there is much conversation regarding the advantages and limitations of indiv

SUBMITTER: Satyamitra MM 

PROVIDER: S-EPMC9063325 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature