Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals

A workshop was held to critically discuss the need for a non rodent species and the role of the dog in regulatory toxicity testing of pharmaceuticals: to discuss opportunities to reduce and refine the use of dogs in preclinic al toxicology: and to identify a number of specific recommendations which c ould be feasibly achieved to move the process forward. To facilitate a prel iminary evaluation of the contribution of dog studies to the risk assessmen t process, anonymised, unpublished data were provided from fully evaluated, repeat - dose toxicity studies in the rat and dog. Results of the Internat ional Life Sciences Institute (ILSI) Human Toxicity Project were also prese nted and discussed. Analysis of the data demonstrated that the dog can prov ide additional toxicity information, which, in some cases, was shown to be predictive for humans. Discussions indicated that there is potential for ac hieving a reduction in dog use and several possible approaches were identif ied. To further the progress of this initiative, there is a need to collate the results of pharmacology, toxicology, and clinical studies to address s ome of the proposed approaches. One of the outcomes of the workshop will be the establishment of a steering group to co-ordinate data collation for Fu rther analysis.