Sentences with phrase «exposing healthy human volunteers»
The rule provides a framework for potential licensure of medical products when definitive efficacy studies that would involve exposing healthy human volunteers are unethical and field trials after accidental human exposure are not feasible.
To do this, the research team enrolled 65 healthyvolunteers aged 18 to 50 years in the human challenge study — a type of research study in which individuals are exposed to disease - causing pathogens under carefully controlled conditions.