Conduct of Shorter Duration Carcinogenicity Study using Transgenic rasH2 Mice
USFDA has recently approved substitution of the traditional 2 year (78 weeks) rodent carci study with a 6 month (26 weeks) study in the rasH2 transgenic mice.
This is based on the propensity of these knock-out mice to develop tumors earlier in their lifespan, thus shortening the overall duration of the study.
The team developed systems and processes to handle sensitive transgenic mice
There was no undue mortality and morbidity, and the positive control data developed for MNU (N-Nitroso-N-Methylurea) and urethane met the validation requirement for development of neoplastic changes. The report was successfully submitted.
This represents a rare achievement in preclinical tox testing only a handful of labs in the world have experience in performing this type study.