Test Area
Toxicity CRO - Carcinogenicity study
- It refers to a test in which a test article is administered to animals over a long period of time to qualitatively and quantitatively evaluate whether cancer (tumor) is induced.
Services
- 24 Months Carcinogenicity Study using rats
- 18 to 24 Months Carcinogenicity Study using mice
- Short-term Carcinogenicity study in transgenic mice (e.g. p53 mouse, rasH2 mouse)
- Tumorogenicity Study using nude mice or rats
Study types
- Long- extended period (maximum of two years) to identify a tumorigenic potential.
According to the ICH S1 guidance, short-term mouse Carcinogenicity study using a transgenic model can replace the full two-year mouse/rat carcinogenicity studies as an alternative.
- There are concerns over biologics products, including cell therapy products, due to the tumorigenic potential from the possible unintended contamination of undifferentiated cells or transformed cells. So, we offer the tumorigenicity study using nude rodents for evaluating potential tumorigenicity in the tumorigenicity study.
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There are concerns over biologics products, including cell therapy products, due to the tumorigenic potential from the possible unintended contamination of undifferentiated cells or transformed cells. We offer the tumorigenicity term rodent carcinogenicity studies involve exposing rodents to a test article for an study using nude rodents for assessing potential tumorigenicity.
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