Safety_Assessment_lungs




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.


 


FPWBP – When conscious, unrestrained approaches are desired, FinePointe whole body plethysmography allows for respiratory endpoints to be obtained. With the use of a bias flow supply, longer data collection periods can be obtained; allowing for evaluation of compounds that might have an effect beyond 4-6 hours post dose.

Learn more about FinePointe whole body plethysmography products.

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Head-Out Plethysmography  - Using Allay restraints, animals are comfortably and properly secured in plethysmographs without compromising the thorax to obtain consistent and reliable direct flow measurements. 

Learn more about head-out plethysmography products from DSI.

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FPRC - FinePointe resistance and compliance hardware helps researchers measure an animal’s airflow and lung pressure. This anesthetized approach allows for direct measurement pulmonary function as a follow up study to the core battery requirements.

Learn more about FinePointe resistance and compliance hardware.

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FPNAM - Conscious follow up studies for safety pharmacology and longitudinal toxicology studies alike can take advantage of the FinePointe non-invasive airway mechanics station. Using specially designed Allay restraint and double chamber plethysmography, nasal and thoracic flow can be monitored simultaneously to derived specific airway resistance.

Learn more about FinePointe non-invasive airway mechanics products.

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FinePointe Software – FinePointe software is powerful and easy-to-use for collecting, analyzing, and reporting life science data. Fully network-enabled, the smart design minimizes required user interaction while wizards walk users through necessary procedures.

Learn more about Buxco FinePointe software from DSI.

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References

Safety Pharmacology Society Website: http://www.safetypharmacology.org/about_sps.asp

Guidance for Industry - S7A Safety Pharmacology: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074959.pdf.%22

International Council for Harmoinisation website: http://www.ich.org/home.html

Society of Toxicology Website: http://www.toxicology.org/