Safety pharmacology core battery: Respiratory system
The aim of this type of study is to evaluate the effects of the test item on the respiratory functions using Whole Body Plethysmography in freely moving animals.
In mice or rats.
- Limit test or 3 dose group design (compared to one dose of positive control and a negative control)
- In 2 sexes if sex differences are expected
- Optional with exposure control at Cmax
Respiratory parameters are recorded and evaluated comparing to the pre-values and to the data gained from vehicle and positive control animals:
- Inspiratory time
- Expiratory time
- Peak inspiratory flow
- Peak expiratory flow
- Tidal volume
- Respiratory rate
- Relaxation time
- Enhanced pause