Issues in 2-year long-term in vivo carcinogenicity assay = 2년 장기 발암성 검색법의 이슈

Abstract

It has been debating about conducting and interpretating of 2year rodent carcinogenicity bioassay. Although some criticisms arising in usefulness, it has been still known that longterm 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.