Experiments are designed to generate adequate and robust data in exploratory and regulatory areas using both in vitro and in vivo models. Preclinical evaluation studies are conducted in different modules per the sponsor requirements and in accordance with national and international guidelines (ICH and US FDA, OECD)
NCEs are screened using in vitro systems to facilitate lead optimization and lead identification and in vivo models like mice, rats, guinea pigs, rabbits and beagle dogs through different routes for proof of principle, fast track kinetics and safety assessment, all with GLP compliance.
Institute for Industrial Research & Toxicology
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