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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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