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ES Feature: Animal extrapolation. A look inside the toxicologist's black box.

This paper discussed problems associated with predicting human response to a carinogen based on the results of lifetime animal model studies. Members of the regulatory community have tended to view the predictive models of the toxicologist in much the same way as the engineer's black box, without understanding what was going on inside it. Regulators accepted what the model told them as directly applicable to humans. The author offered a look inside the toxicologist's black box of animal modeling to begin to estimate the extent to which past regulatory actions have been consistent with biological reality. The focus of the article was on three areas of critical importance to the field of predictive toxicology and risk assessment that are used to determine the adequacy of predictive models. These areas were the predictive relevance of mouse hepatomas, the role of physiologically based pharmacokinetic models in risk assessment, and the capacity of current animal models to deal with the occurrence of human heterogeneity in their predictions of human responses.