Alternative Partnerships
The use of alternative models to identify carcinogens have generated a lot of interest because these studies require fewer animals and shorter exposure times which would allow more chemicals to be screened and would reduce costs. Under the mission objectives of the International Congress on Harmonization to examine whether the need for long term studies in two species could be reduced, the U.S. Food and Drug Administration is proposing revisions to their testing guidelines for carcinogenicity of pharmaceuticals. One of the options under consideration as a replacement for a second rodent species long-term bioassay is the use of genetically-manipulated mice or other alternative models to assay for carcinogenic potential. Members of the pharmaceutical industry have expressed interest in forming partnerships with Federal Agencies to exchange study information on the utility of genetically-altered mice and other alternative model systems to screen chemicals for toxicity. This partnership effort was coordinated by the International Life Sciences Institute.
A concensus list of pharmaceutical drugs was defined to include a variety of classes and participants have volunteered to conduct studies with these drugs in transgenic or other alternative models using standardized protocols. Results from these studies were used to evaluate the strengths and limitations of the models systems. (See Toxicologic Pathology, volume 29, Supplement, 2001)
Overview of the models evaluated.
