title: Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals.
abstract: A workshop was held to critically discuss the need for a nonrodent 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 preclinical toxicology; and to identify a number of specific recommendations which could be feasibly achieved to move the process forward. To facilitate a preliminary evaluation of the contribution of dog studies to the risk assessment process, anonymised, unpublished data were provided from fully evaluated, repeat-dose toxicity studies in the rat and dog. Results of the International Life Sciences Institute (ILSI) Human Toxicity Project were also presented and discussed. Analysis of the data demonstrated that the dog can provide additional toxicity information, which, in some cases, was shown to be predictive for humans. Discussions indicated that there is potential for achieving a reduction in dog use and several possible approaches were identified. To further the progress of this initiative, there is a need to collate the results of pharmacology, toxicology, and clinical studies to address some 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 further analysis.
authors: Fund for the Replacement of Animals in Medical Experiments, Nottingham, UK.
authors: C L
authors: CL
authors: Broadhead
authors: G
authors: G
authors: Betton
authors: R
authors: R
authors: Combes
authors: S
authors: S
authors: Damment
authors: D
authors: D
authors: Everett
authors: C
authors: C
authors: Garner
authors: Z
authors: Z
authors: Godsafe
authors: G
authors: G
authors: Healing
authors: R
authors: R
authors: Heywood
authors: M
authors: M
authors: Jennings
authors: C
authors: C
authors: Lumley
authors: G
authors: G
authors: Oliver
authors: D
authors: D
authors: Smith
authors: D
authors: D
authors: Straughan
authors: J
authors: J
authors: Topham
authors: R
authors: R
authors: Wallis
authors: S
authors: S
authors: Wilson
authors: P
authors: P
authors: Buckley
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D004285:Dogs; D004341:Drug Evaluation / Q000379:methods*; D015507:Drugs, Investigational / Q000633:toxicity*; D066298:In Vitro Techniques; D051381:Rats; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment; D013045:Species Specificity; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D015507:Drugs, Investigational