Fraunhofer ITEM
Fraunhofer institute for toxicology and experimental medicine providing GLP inhalation toxicology, respiratory disease models and translational research under contract.
About Respiratory Safety
Respiratory function is one of the three vital systems in the ICH S7A safety pharmacology core battery, alongside the cardiovascular and central nervous systems. The standard study measures respiratory rate, tidal volume and minute volume in conscious rodents using whole-body or head-out plethysmography, usually after a single dose at and above the expected clinical exposure.
Programs with a respiratory signal, or drugs delivered to the lung, may need more: pulmonary function testing in anesthetized animals, blood gas analysis, or respiratory endpoints built into non-rodent telemetry studies. Inhaled products also require inhalation toxicology, where the exposure system, aerosol generation and particle size characterization are specialized capabilities that only some labs offer.
If your program involves inhalation dosing, ask about the exposure system (nose-only or whole-body), aerosol monitoring and which species the lab has run by inhalation, since not every CRO listed for respiratory safety runs inhalation toxicology.
Respiratory Safety Pharmacology CROs
Showing 1 CRO. Order rotates daily so no lab is permanently listed first.
Questions to ask when choosing a Respiratory Safety CRO
- Do you use whole-body or head-out plethysmography, and in which species?
- Can respiratory endpoints be added to our cardiovascular telemetry or toxicology study?
- Do you run inhalation toxicology, and do you use nose-only or whole-body exposure?
- How do you characterize aerosol concentration and particle size during inhalation dosing?