Safety Pharmacology has recently emerged as an important component in the discovery and development of a wide range of pharmaceutical and chemical products. The goal of drug development is advancing novel drugs that provide true health benefits by optimizing efficacy with minimal or no adverse effects. Prior to approving a drug for clinical trials, the TGA/FDA and other regulatory agencies require a core battery for safety pharmacology studies in which the effects of a test article on vital functions of the central nervous system, cardiovascular system and respiratory system are evaluated.
The GLP-compliant safety pharmacology models includes
- Cardiovascular Safety Testing
An important safety pharmacology studies evaluate the cardiovascular system in unanesthetised models or Acute anesthetised models. Evaluations are performed in large and small non-clinical test systems. The parameters to be determined include blood pressure, heart rate, ECG etc.
- hERG K+ Ion Channel Assay
A fully validated binding assay for early detection of hERG inhibitor compounds in high-throughput formats.
- Rat Haemodynamics
A comprehensive array of preclinical studies to examine cardiovascular functional changes.