in vivo GLP inhalation toxicolgy

extensive history of inhalation expertise

IITRI has 40+ years of experience running inhaled drug studies including for aerosol challenges and efficacy, environmental risk assessments, occupational health studies, and electronic cigarette (e-cig) and tobacco studies. Our highly experienced team can offer a more customer-centric approach for any Sponsors new to inhalation as a route of administration. 

PRECLINICAL DEVELOPMENT OF INHALED DRUGS

We offer comprehensive preclinical inhalation toxicity testing programs are customized to your needs, whether that is preparing for early preclinical studies, IND submissions, or NDA-enabling inhalation studies. Our expertise covers acute, subchronic and chronic studies, PK and biodistribution including with radiolabeled drugs, developmental and reproductive toxicology (DART), and carcinogenicity studies. 

Our proprietary bioaerosol system allows for nose-only exposure of mice, rats, rabbits, canines, and nonhuman primates (NHPs). Exposure atmosphere characterization is performed prior to any study initiation to determine particle size distribution, in-air test article concentration, and dose exposure times are acceptable for lung deposition of particles for the study. We have experience handling difficult materials including solids, liquids, and gasses depending on your study needs.

We also offer whole body inhalation exposure (rodents), oronasal inhalation exposure (large animals), intranasal dosing, and API-sparing dry powder or liquid intratracheal administration for use with limited availability of test article. Our ABSL-2 and ABSL-3 facilities allow us to test aerosolized drugs for relevant infectious disease animal models, in addition to our ability to aerosolize agents for challenge as well. 

Occupational and environmental 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 such as OECD 403 and OECD 414. These are often to test potential inhalation hazards stemming from pesticides, chemicals, and metals. Animal Rule studies are also an option for situations in which human challenge studies are not ethical or feasible.