Test Area
Safety pharmacology evaluation
- Safety pharmacology studies investigate potential undesirable pharmacodynamic effects of a test article on physiological function in relation to exposure in the therapeutic range and above.
- The data of safety pharmacology studies are among the data that must be submitted for review for FDA Investigation New Drug (IND) application.
- International regulations for safety pharmacology studies include ICH S7A and ICH S7B which introduce an overview of safety pharmacology studies and provide a rough test method for the core battery tests that must be performed during safety pharmacology studies.
Services
- General pharmacology
- Safety pharmacology
Study types
- General behavior test
- CNS study
- PNS study
- Respiratory study
- Cardiovascular study
- Gastro-intestinal study
TOP
ChemOn Inc