ABSTRACT
The identi¢cation of animal models for the prediction of systemic toxicity in man for drugs and chemicals has been the subject of research and scienti¢c debate for decades. The use of an animal model in toxicology is at times based on convenience and, to a certain degree, economics rather than applicability to man. In pharmaceutical development, in vivo and in vitro skin penetration studies play a key role in the selection of topical drugs for further clinical development. Over time, it has been recognized that attention must be paid to the similarities of animal models with those of humans in order that safety and risk-assessment extrapolations can lead to a scienti¢cally defensible margin of safety. Kahn (1984) reviewed the known physiology of miniature swine (minipig) showing that this species offered many advantages in terms of physiological similarities. Indeed, the author stated that, in 1984, this species was an ‘unappreciated and underutilized’ (p. 337) animal model. McAnulty (1999) and Kurihara-Bergstrom et al. (1986) recognized the role of the minipig in drug development and toxicology with the latter investigators, with a host of others, examining the similarities between the skin of this animal model and human skin. Since that time, however, as reviewed by Svendsen (2006), Mortensen et al. (1998) and Mahl et al. (2006), this species continues to be used as a preferred animal model for safety assessment of, for example, pharmaceuticals, particularly where the drug is to be administered topically to man.
