In vitro and in vivo studies validating the efficacy of new drugs using cell lines and animal models.
Safety evaluation including genotoxicity, safety pharmacology, and general toxicity in rodents and non-rodents.
MTD, DRF, acute and repeated dose studies, sub-chronic and chronic toxicity evaluations.
Dermal, eye, oral, and mucus membrane irritation/corrosion tests to ensure product safety.
The pharmacology studies (efficacy) most frequently consist of in vitro (cell Line) and in vivo (Animal) experiments that validates the potential of desired effect of the new drug or test compound. This is often done in animal models that mimic human disease. The Toxicology studies (safety) evaluate the safety profile of the drug. This includes assessing the effect on DNA (genotoxicity), critical organ systems i.e., effects on cardiovascular, respiratory, and central nervous system (safety pharmacology), and general toxicity (rodent and nonrodent species).
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