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