Predictivity of animal studies for human injection site reactions with parenteral drug products

The value and predictive power of nonclinical studies for potential effects of investigational medicinal products in humans is often debated. The subject of general predictivity of animal toxicity studies has been addressed on several occasions, with one of the most recent efforts being conducted by an ILSI Task Group [Olson H, et al. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000; 32: 56–67]. This review provides a summary of the evaluation of cutaneous toxicity, its histopathological assessment, and experience of the biopharmaceutical industry with respect to injection site reactions with parenteral drug products with a pragmatic perspective on the predictivity of standard animal studies with respect to these responses in humans.