ABSTRACT
OVERVIEW Preclinical animal data are an integral component of the product development process, being used for predicting the potential for drug toxicity and for estimating first-time doses in humans. These extrapolations are based upon an assumption of a correlation between the exposureresponse relationship in animals and man. Unfortunately, there is no single animal species that can serve as the “perfect” surrogate for human subjects, and the appropriate surrogate species needs to be evaluated for each situation (1).
