Investigating the undesirable pharmacodynamic effects of drugs
Safety Pharmacology studies aim to identify the undesirable pharmacodynamic effects of a substance on physiological functions when exposed to the substance in the therapeutic range and above. Safety Pharmacology studies apply to new chemical entities (NCEs) and biotechnology-derived products. Regulatory guidelines (ICH S7A & S7B) mandate conducting core battery safety pharmacology studies with an investigational drug. This is to study the new drug’s effect on cardiovascular, respiratory, and central nervous system functions before administration in humans.
Our team is experienced in stand-alone as well as the integrated repeat-dose design of safety pharmacology studies.
- Central nervous system studies: Functional observation battery (FOB) / modified Irwin test
- Cardiovascular system studies: HERG and Dog telemetry (using partner sites)
- Respiratory system studies: Whole body plethysmography