Safety pharmacology investigates the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range or above. Safety pharmacology is one of the important components of the nonclinical safety assessment of drugs, which focuses on the effects of drugs on the central nervous, cardiovascular, and respiratory systems, with additional and/or complementary safety pharmacology studies as required.
TriApex can conduct safety pharmacology studies in compliance with NMPA, FDA and OECD regulations and guidelines. Our safety pharmacology team members, with multiple backgrounds such as pharmacology, toxicology, veterinary medicine, are experienced and skillful in the safety pharmacology core battery, and capable to evaluate the effects of the test article on central nervous, cardiovascular and respiratory systems in non-human primates (NHPs), dogs, mini pigs, rats and mice.
1. Cardiovascular System
-Implanted telemetry and jacketed external telemetry in NHPs and Beagle dogs (heart rate and ECG)
-Implanted telemetry and jacketed external telemetry in mini pigs (heart rate and ECG)
-In vitro hERG test (IC50)
2. Respiratory System
-Implanted telemetry and jacketed external telemetry in NHPs and Beagle dogs (respiratory frequency and tidal volume, etc.)
-Whole-body plethysmograph (WBP) in rats and mice (respiratory frequency and tidal volume, etc.)
3. Central Nervous System
-Functional Observational Battery (FOB) evaluation in NHPs and Beagle dogs
-Modified Irwin test in rats and mice
-FOB evaluation in rats
-EEG test (in validation)
-Rotary rod test
-Spontaneous activity test, etc.
-To screen the potential effects of the test article on specific systems (central nervous system, cardiovascular system, or respiratory system) in the early stage of drug development (non-GLP).
-To comprehensively evaluate the effects of the test article on central nervous, cardiovascular and respiratory systems (GLP).
TriApex completes safety pharmacology studies of dozens of test articles every year.
We adopt different evaluation strategies for different test articles:
For small molecule drugs, independent safety pharmacology studies such as cardiovascular and respiratory system study in Beagle dogs and modified Irwin assay in rats will be adopted.
For biotechnological drugs, the safety pharmacology studies, including cardiovascular and respiratory system studies and FOB testing, are usually conducted with the repeat dose toxicity studies.
A "Case by Case" strategy is used to comprehensively evaluate the effects of the test article on the central nervous, cardiovascular and respiratory systems.