VIMTA has extensive experience in conducting a comprehensive range of safety pharmacology studies for pharmaceuticals and other chemicals in accordance with internationally recognized guidelines, including ICH S7A, ICH S7B, and the Central Drugs Standard Control Organization (CDSCO) requirements. These studies help characterize the potential adverse effects that a drug or new chemical entity (NCE) may produce, enabling an informed assessment of its safety profile, toxicity, and therapeutic benefit.
Our Core Safety Pharmacology Battery includes:
- In Vitro hERG assay (CHO / HEK)
- Pulmonary function assessment in rats using Whole-Body Plethysmography (EMKA Technologies, Paris, France)
- Neurobehavioral assessment in rats using the modified Irwin’s test
- Cardiovascular assessment in dogs using non-invasive jacketed telemetry
Supplemental / Follow-Up Studies
If any adverse effects are observed during the core safety pharmacology battery, they are further investigated through supplemental or follow-up studies to better understand their significance and underlying mechanisms.
Central Nervous System Safety
- Rota Rod assessment for evaluating motor coordination in rats
- Locomotor activity assessment in rats using an activity meter
Key Supplemental Studies
- Renal / Urinary System: Urinary volume, specific gravity, pH, electrolyte balance, protein, and related parameters
- Gastrointestinal System: Gastric secretion, gastric pH, gastrointestinal transit, and related parameters
