Regulatory Toxicology. James Swenberg, D.V.M., Ph.D. Acute Toxicity Studies. Single dose - rat, mouse (5/sex/dose), dog, monkey (1/sex/dose) 14 day observation In-life observations (body wt., food consumption, clinical observations) Necropsy . Acute LD50 Values vs Toxicity.
James Swenberg, D.V.M., Ph.D.
Variability of endpoints
Pathology Working Group
Statistics vs biology
Mechanistic factorsCarcinogenicity Study Evaluation Issues
AnalogyBradford Hill Criteriafor Cancer Causation
Postulated mode of action
Strength, consistency and specificity of association with key events
Biological plausibility and coherence
Other modes of action
Assessment of mode of action
Uncertainties, inconsistencies and data gapsIPCS/EPA Framework for Evaluating Mechanistic Data
Exposure-Dose-Response Continuum and the Evolution of Protective to Predictive Dose-Response Estimates