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Pre-Clinical Safety Evaluation (PCSE) ::
Key Role:
To facilitate laboratory animal housing and surgical facilities for rodents. PCSE breeding facility provides various species/strains of rodents for efficacy studies of in house NCEs research. The Toxicology department conducts pre-clinical safety/toxicity studies on rodents for NCEs. It also provides pathology support to pre clinical safety and efficacy studies.
This facility is exclusively for in-house studies and not for any contract research.
Key Capabilities:
- Exploratory toxicity studies for lead selection and monitoring of early biomarkers of toxicity
- Single dose toxicity studies
- Repeat dose toxicity studies - 2 weeks to 26 weeks
- Functional observational battery of test in rodents (modified Irwin test)
- In vivo Genotoxicity studies
- Toxicokinetics and Tissue Distribution studies
- Local tolerance test
- Skin sensitization test in Guinea pigs
- Embryo-fetal toxicity
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