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Safety Assessment/Toxicological Studies

Conduct rigorous assessments of drug safety to provide compliant safety evaluation support for IND submissions.

Single‑dose and repeated‑dose toxicity studies: Thoroughly assess the acute and chronic toxicological responses in animals, accurately defining the drug’s safety margin and identifying target organs of toxicity.

Safety pharmacology studies: These focus on assessing the effects of investigational drugs on the respiratory, central nervous, and cardiovascular systems, including assays such as the hERG potassium channel blockade assay.

Genotoxicity and Reproductive Toxicity: Standard genotoxicity assessments, including the Ames test, chromosome aberration assay, and micronucleus assay, are conducted.

Local toxicity assessment: Includes standard hemolysis, irritation, and sensitization tests.