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Issues in 2-year Long-term in vivo Carcinogenicity Assay  

Son, Woo-Chan (Huntingdon Life Sciences, Pathology, UK)
Kim, Bae-Hwan (Pre-clinical Research Center, AMOREPACIFIC R&D CENTER)
Jang, Dong-Deuk (Division of Toxicological Research, National Institute of Toxicological Research, Korea Food and Drug Administration)
Han, Beom-Seok (Division of Toxicological Research, National Institute of Toxicological Research, Korea Food and Drug Administration)
Kim, Jong-Choon (Department of Toxicology, College of Veterinary Medicine, Chonnam National University)
Lee, Je-Bong (National Institute of Agricultural Science and Technology, Rural Development Administration)
Shin, Jin-Sup (National Institute of Agricultural Science and Technology, Rural Development Administration)
Kim, Hyoung-Chin (Lab of Animal Model Evaluation, Korea Research Institute of Bioscience and Biotechnology(KRIBB))
Publication Information
The Korean Journal of Pesticide Science / v.8, no.4, 2004 , pp. 239-254 More about this Journal
Abstract
It has been debating about conducting and interpretating of 2-year rodent carcinogenicity bioassay. Although some criticisms arising in usefulness, it has been still known that long-term carcinogenicity studies using rodents would be the only assay system to predict any possible human risks, which would not be replaced. Both regulatory agencies and academies have developed some assay models, however, there have been controversy whether those study designs and interpretations are based on sound scientific rationale and validated data. Such kinds of issues including choice of species/strain, dose level selection, duration of study, number of animals per group, historical control data, monitoring parameters, terminal investigations, peer review, statistics, alternative assay models, interpretation of neoplastic lesions, and risk assessments, were reviewed.
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