VIMTA has been performing battery of safety pharmacology studies for pharmaceutical and other chemicals using internationally recognized guidelines including ICH S7A and S7B, and Central Drugs Standard Control Organization (CDSCO) requirements for conducting safety assessments. The studies help in characterising the potential extent of injury that a drug or NCE can produce and arrive at a risk-benefit equation to determine the toxicity and efficacy.
The core battery includes following studies:
- In VitroHERG Assay (CHO / HEK)
- Pulmonary function in rats by means of Whole-Body Plethysmography (EMKA technologies, Paris, France)
- Neurobehavioral parameters in rats through modified Irwin’s test
- Cardiovascular assessment in dogs using non-invasive jacketed telemetry
Supplemental / Follow Up Studies
If any adverse effect is suspected during performing core battery for safety pharmacology, they are further explored in supplemental or follow up studies.
Central Nervous System safety
- Rota Rod Assessment for evaluating motor coordination in rats
- Locomotor Activity Assessment in rats by activity meter
Key Supplemental Studies
- Renal / Urinary System: Urinary volume, specific gravity, pH, electrolyte balance, protein etc
- Gastrointestinal System: Gastric secretion, gastric pH, gastrointestinal transit etc