Animal studies expose laboratory species to controlled doses and observe effects. Extrapolation to humans requires assumptions about interspecies differences in metabolism, sensitivity, and relevant dose scaling.
High-dose animal exposures frequently exceed human exposure by orders of magnitude.
Alternative Names:
Animal Data Extrapolation, Toxicological Extrapolation
Why it Matters?
The dose disparity is the central limitation, since animal studies commonly use maximum tolerated doses far exceeding realistic human exposure, and effects observed at those levels may not occur at lower ones. Species differences in metabolism are the second issue, because a compound metabolized differently in rodents may not produce the same effect in humans. Animal data alone rarely establishes general causation where human epidemiology exists and is negative.
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Frequently asked questions
What limits animal study extrapolation?
Can animal data alone establish causation?
