Nose-only inhalation exposures to rats/canine*/swine*
- Acute Inhalation study (4 hours continuous exposure or based on requirement)
- Repeat dose 7 to 14 days Inhalation study (6 hours continuous exposure/day or based on requirement)
- Repeat dose 28 days Inhalation study (6 hours continuous exposure/day or based on requirement)
- Repeat dose 90 days Inhalation study (6 hours continuous exposure/day or based on requirement)
Facilities:
- Powders: Dust exposure using dust generator
- Liquids/solids: Aerosol generation with suitable vehicle
- Technical pre-test/s without animals to check the feasibility of generating adequate test atmosphere (test item concentration, particle size distribution, O2, CO2, temperature and humidity)
- Preliminary test/Dose range test with animals
- Mass Median Aerodynamic Diameter (MMAD) and Geometric standard deviation (GSD), determination using cascade impactor
- Chamber environment monitoring- O2,CO2, temperature and humidity
- Estimation of test item concentration at the animal?s breathing zone using In-house developed & validated analytical method like HPLC/GC or Gravimetric -filter paper analysis
- Animal observation, clinical pathology, Broncho alveolar lavage analysis, immunohistochemistry
- Pharmacokinetics/Exposure in blood and/or tissues
- Full gross pathology and histopathology
*Studies performed at a strategic partner laboratory
