Safety Studies

Ames test: In vitro genetoxicity studies are performed under non-GLP conditions to assess a drug molecule’s mutagenic potential using Salmonella strains under US FDA and OECD guidelines.

CHO-hERG channel binding assay: Binding assay to evaluate cardiac toxicity of the test item

Chromosomal aberration study: To identify a test item’s potential to cause structural chromosomal aberrations in cultured mammalian cells under OECD guideline 473 and non-GLP.

Mouse lymphoma: Mammalian cell gene mutation test to identify the mutagenic potential of the test item as per OECD guideline 476 under non-GLP.

Hepatotoxicity: Drug induced liver damage is evaluated by using primary hepatocytes (LDH release or Neutral red uptake assays)

Bone Marrow Toxicity: Evaluated by clonogenic assay using soft agar method in rat, mice, human and canine bone marrow cells