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epidemiological studies and by submission of Adverse Reactions to Drug Reports to FDA.
Epidemiology studies of humans evaluate whether there is a causal relationship between exposure to a substance and adverse health effects.
A generally accepted thesis in toxicology is that toxicity found in animal studies usually occurs with similar incidence and severity to that observed in humans. Animal tests have advantages over human studies in that the chemical exposure and environmental conditions can be precisely controlled, virtually any type of effect can
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