Abstract
Conventions for assessing human health risks for contaminants, food additives, and other regulated products have largely centered around using animal experiments. Under this framework, epidemiological studies in humans, particularly observational studies, are often considered a secondary source of evidence. In this chapter, it is argued that the major strength of both observational and experimental studies in humans lies in their high external validity. That is if properly used and integrated with other lines of evidence the uncertainty of the animal to human extrapolation can be reduced or even eliminated. The limitations of assessing evidence by study design are explained with different examples. Areas of uncertainty associated with characterizing risk based on a few selected studies, judged to be of high quality, are also discussed. It is concluded that to allow for better integration of human epidemiology in risk assessment further development of evidence-based medicine should provide more room for expert judgment and mechanistic understanding.
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