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Interest in the use of animal models of human disease has been increasing both within pharmaceutical companies and regulatory authorities, as evidenced by several recent publications and inclusion of recommendations for the use of these models in regulatory guidances. While the use of conventional or healthy animal models will continue to be a central component of safety evaluation, there are certain instances in which the use of animal models is critical for the understanding of potential risk for a diseased population. This review article provides highlights of the use of animal models of disease and provides examples of recent uses of animal models in the elucidation of safety considerations for humans, focusing on instances in which the models have been utilized in regulatory filings.