Lung function endpoints are commonly obtained when conducting disease related pharmacology studies (fibrosis, asthma, etc.) However, similar endpoints are desired in safety pharmacology and toxicology groups as well. The safety pharmacology and toxicology studies have to be performed in compliance with the GLP Principles.
The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. Lung function tests in conscious animals are a requirement to the core battery. Follow up studies may be required if adverse effects raise concern for human safety.
Respiratory toxicology studies are performed on pharmaceuticals or chemicals when inhalation is the primary route of exposure or when the airways are the focus of interest.
Most studies are performed in rodents; rats being the primary choice. When warranted, other species are considered. Although respiratory rate and tidal volume are the typical endpoints desired, many additional derived parameters and supplemental pulmonary function measurements are available.
DSI solutions help assess the impact of compound and their potential side effects on major organ systems.