IND & NDA enabling studies, Impurity qualification & Bridging studies for regulatory submissions & 505 (B2) strategies.
IND-enabling studies
IND-enabling studies are performed to evaluate the efficacy and safety of the new drug.
The pharmacology studies (efficacy) most frequently comprise of in vitro (cell based) and in vivo (whole animal) experiments that validates the potential of desired effect of the new drug. This is often done in animal models that mimic the 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).
During the IND-enabling studies, the data explains systemic exposure to the drug, the exposures and nature of adverse effects at high dose levels, and the safety margin.
Exploratory toxicology
DMPK studies
Mammalian toxicology
Genetic toxicology testing
Analytical / bioanalytical capabilities
Safety pharmacology studies
