Current status and use of short/medium term models for carcinogenicity testing of pharmaceuticals--scientific perspective.
Short- and medium-term rodent bioassays have been proposed under ICH guidelines for use in testing for the carcinogenic potential of pharmaceuticals. Further evaluation of these models is needed urgently and coordinated efforts are in progress worldwide to expand the available database. Models currently being investigated include transgenic mice (Tg-rasH2, Tg.AC, p53(+/-), XPA(-/-)) and neonatal mice. As more data become available on the performance of these assays, regulatory and industry scientists will be faced with the difficult challenge of determining how the performance (accuracy) of each assay will be measured and deciding which assays have value in the risk assessment process.
Storer
R D
RD
Department of Genetic and Cellular Toxicology, Merck Research Laboratories, WP45-311, West Point, PA, USA. richard_storer@merck.com
D000818:Animals; D000831:Animals, Newborn; D001681:Biological Assay; D015197:Carcinogenicity Tests / Q000379:methods*; D004195:Disease Models, Animal; D004345:Drug Industry; D051379:Mice; D008822:Mice, Transgenic; D008957:Models, Genetic; D009374:Neoplasms, Experimental / Q000235:genetics*