Appropriate Species

In the early stages of the development of any drug, there is little, if any, information on which to make a scientific judgment relative to the most appropriate animal species for non-clinical studies that will best predict responses in the human. In these cases, since regulatory agencies require the use of both a rodent and a non-rodent species, the typical approach would be to use the rat and the dog for the toxicity studies, and mice or rabbits for other more specialized studies. Primates may be needed when there is availability of considerable background data in these species in terms of the parameters of interest (hematology, blood chemistry, histopath-ology, etc.). When candidate drugs are proteins (e.g. animal-derived monoclonal antibodies), then antibody formation may be major issue and may dictate the choice of species. For example, it may be known that only the chimpanzee does not develop neutralizing antibodies to the drug, which would lead one to select that species as the non-clinical model. Topical formulations are another special case, and the rabbit is commonly employed. The selection of the animal species for the non-clinical program is often not straightforward.

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