Safety pharmacology core battery: Respiratory system
Aim:
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.
Species:
In mice or rats.
Design:
- 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
Outcome:
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
