Dose–response assessments incorporate both qualitative data (e.g., does a lesion exist, and if so what is its severity grade) and quantitative data (e.g., organ weights, cell numbers, and other end points). It characterizes the relationship between variable levels of exposure to a test substance and the shifts in incidence and severity in any responses. Nonclinical toxicity studies are designed to evaluate the conditions under which exposure to the test article might induce an effect, and particularly an adverse effect (i.e., “toxicity”). Ricardo Ochoa, in Fundamentals of Toxicologic Pathology (Third Edition), 2018 Dose–Response Assessmentĭose–response assessment is a critical element of hazard characterization.
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