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논문 기본 정보
- 자료유형
- 학술대회자료
- 저자정보
- 발행연도
- 2021.7
- 수록면
- 101 - 101 (1page)
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Regulatory requirements for the assessment of carcinogenic potential of new drugs typically consist of long-term studies in two rodent species such as rats and mice. This process demands for considerable amount of time and effort along with high expense that it requires sacrifice of a relatively large number of animals to ensure statistical significance. Therefore, International Conference on Harmonization (ICH), which is to achieve greater harmonisation worldwide to ensure development of safe, effective and high quality medicines, recommend that the carcinogenicity study on two rodent models be composed of a long-term carcinogenicity study on rats and a short-term carcinogenicity study on mice. The International Life Sciences Institute of Health and Environmental Science Institute (ILSI HESI) conducted a short-term carcinogenicity study model development project through the Carcinogenicity Test Alternatives (ACT) committee to verify RasH2 Tg and p53+/- mice as suitable carcinogenicity models. It was estim ... 전체 초록 보기
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