IITRI offers comprehensive preclinical inhalation toxicology services for development of inhaled drugs, infectious aerosol challenge studies, occupational health and environmental risk assessments, and electronic cigarette or flavor studies. Our highly experienced team is ready to offer assistance to sponsors who are new to the inhalation route of dosing in preclinical studies.
Electronic Cigarettes and Flavors (E-cigs) or Tobacco Products
IITRI has conducted large studies for the inhalation toxicology testing of cigarette smoke, and we now offer pulmonary toxicology studies for electronic cigarettes and flavors (E-cigs). We established a GLP analytical smoke chemistry program in 2000 for the determination of analytes of cigarette smoke, and are experts in the isolation and analysis of smoke components.
- E-cig and vaping flavors toxicity studies
- Smoke (tobacco products) chemistry and toxicity
Preclinical Development of Inhaled Drugs
Our comprehensive preclinical inhalation toxicity testing programs utilizing pulmonary drug delivery are customized to support GLP-compliant IND submissions for pharmaceuticals and the intended inhalation delivery device. We also offer early preclinical and NDA-enabling inhalation toxicology services for complete end-to-end coverage of regulatory requirements.
- Acute, subchronic and chronic inhalation toxicology studies
- PK and biodistribution: see API-Sparing Techniques for Inhalation Toxicology Studies
- Developmental and reproductive toxicology studies with inhalation exposure
- Carcinogenicity studies
Inhalation Exposure Methods
Our laboratories are well equipped with multi-port inhalation exposure systems to perform nose-only inhalation toxicity studies on mice, rats, rabbits, canines and non-human primates (NHPs). System aerosol characterization is performed prior to study initiation ensuring particle size distribution, in-air test article concentration, and dose exposure times are determined and are acceptable for lung deposition of particles for the study. We offer the following variations on inhalation exposure dosing:
- Nose only or whole body inhalation exposure (rodents)
- Oronasal inhalation exposure (large animals)
- API-sparing dry powder or liquid intratracheal administration for use with limited availability of test article
- Intranasal dosing
Test Article Aerosol Generation Methods
The development of methods for exposure atmosphere generation with a particle size range allowing lung deposition is the first step in any inhalation toxicology study. Our expert staff has decades of experience working with a wide range of chemicals and drugs with complex properties, including:
- Gasses or vapors
- Liquids and suspensions
- Powders, fibers or nanoparticles
- Metered dose inhaler formulations and devices
- Electronic cigarettes or tobacco product smoke
Infectious Disease Aerosol Challenge Studies
We offer high-containment GLP-compliant Biosafety Level (BSL)-2 and BSL-3+ infectious disease aerosol challenge and toxicity studies utilizing inhaled biologics. These include using aerosol pathogen exposure methods for animal model challenge studies, or inhalation drug administration for the treatment of high pathogen infectious agents.
- Proprietary bioaerosol exposure system
- Rodents, rabbits and nonhuman primates (NHPs)
- Viral and bacterial pathogens
Occupational Inhalation Exposure and Environmental Risk
Chemicals, metals and pesticides often must 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.
- OECD 403 (rats)
- OECD 414 (rats, rabbits)
The IITRI Advantage
- Over 30 years of expertise in aerosol science and inhalation exposure study teams including PhD aerosol scientists and DABT toxicologists
- Comprehensive preclinical testing programs available to support IND and NDA submissions for drugs utilizing inhalation drug delivery
- Experience handling difficult materials including solids, liquids, and gasses