IITRI offers comprehensive inhalation toxicology services for inhaled pharmaceutical drug development, infectious disease bacterial or viral pathogen exposure studies, occupational health and environmental risk assessments, and cigarette smoke or e-cigarette studies.
Inhaled Medication Preclinical Development
IITRI offers comprehensive preclinical testing programs available to support GLP-compliant IND and NDA submissions for pharmaceuticals utilizing inhalation as a route of administration. We have over 40 years of experience in the evaluation of potential inhaled therapeutics for respiratory diseases such as asthma, COPD and pulmonary fibrosis.
- Efficacy studies in animal models of pulmonary disease or infectious disease
- Early PK studies: Read our White Paper API-Sparing Techniques for Inhalation Toxicology Studies
- Acute, subchronic and chronic toxicology studies
- Reproductive toxicology studies
- Carcinogenicity Studies
Infectious Disease Challenge Studies
We offer high-containment GLP-compliant Biosafety Level (BSL)-2 and BSL-3+ infectious disease drug development studies. These include using aerosol pathogen exposure methods for the development of animal models, or drug delivery by inhalation for the treatment of high pathogen infectious agents.
- Proprietary bioaerosol exposure system
- Rodents, rabbits and nonhuman primates (NHPs)
- Viral and bacterial pathogens
Occupational Exposure and Environmental Risk
Chemicals, metals and pesticides are often required to be tested for potential occupational or environmental health hazards with inhalation exposure. Occupational inhalation toxicology studies are conducted in all relevant animal models in accordance with testing guidelines of the FDA, EPA, OECD and other regulatory agencies to determine potential health risks.
Cigarette Smoke and Vaping
IITRI has extensive experience conducting large studies for the inhalation toxicology testing of cigarette smoke, electronic cigarettes and flavors (Ecigs) and tobacco products. We also established a GLP analytical smoke chemistry program in 2000 for the determination of analytes of cigarette smoke.
- Electronic cigarettes (Ecigs)
- Smoke (tobacco products)
Inhalation Exposure Methods
Our laboratories are well equipped with multi-port inhalation chambers and monitoring systems to perform various types of inhalation exposures on mice, rats, rabbits, canines and non-human primates (NHPs), including:
- Dry powder insufflation or microspray intratracheal administration for use with limited availability of test article
- Nose only or whole body inhalation exposure (rodents)
- Oronasal inhalation exposure (large animals)
- Nasal dosing
Test Atmosphere Development
The development of methods for atmosphere generation is the first step in any inhalation exposure. Our expert staff has decades of experience working with a wide range of chemicals and drugs with complex properties, including:
- Gas or vapors
- Liquids and suspensions
- Powders, fibers or nanoparticles
- Metered dose inhaler formulations and devices
- Electronic cigarettes or tobacco product smoke
The IITRI Advantage
- Expertise in aerosol science and inhalation exposure—our team includes PhD aerosol scientists in addition to DABT toxicologists
- Comprehensive preclinical testing programs available to support IND and NDA submissions for drugs utilizing inhalation as a route of administration
- Personalized program design to meet your specific needs including non-standard and customized studies
- On-site bioanalytical laboratory to support GLP requirements for toxicology studies