IITRI has the unique advantage of expertise with multiple non-human primate (NHP) animal models (cynos, african green monkeys, and marmosets) and comprehensive preclinical inhalation services for efficacy, safety, and toxicology programs. Our studies range from development of inhaled drugs, infectious aerosol challenge studies, occupational health and environmental risk assessments, and electronic cigarette or flavor studies. We also can offer hands-on support to sponsors who are new to the inhalation route of dosing in preclinical studies.
Pesticides, chemicals, and metals are often best 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. In some cases, NHPs are overlooked due to cost but provide a necessary comparison to human health effects for these studies. Our team recently contributed to a new publication in Chemico-Biological Interactions on the impact of solvents on toxicity for the insecticide parathion delivered by aerosol in macaques.
For efficacy studies, our experienced staff of aerosol scientists and inhalation toxicologists can aid in the method development and testing of both inhaled drugs and infections by aerosol. IITRI is also in the process of expanding our animal biosafety level 3 (ABSL-3) capacity again which allows for larger challenge studies for vaccines or therapeutics to be conducted, including in non-human primates. Our laboratories are well equipped with multi-port inhalation exposure systems to perform nose-only inhalation studies in all relevant species. We can also conduct head-only aerosol infections by inhalation exposure and plethysmography capabilities. NHPs are often uniquely suited for preclinical efficacy studies due to their evolutionary proximity and physiological similarity to humans. This makes these studies more translatable to clinical disease especially assessing the immune response elicited by vaccine before moving to human trials. Infection by inhalation of aerosolized pathogens may dramatically increase the lethality of some agents or may be the primary mode of transmission in humans. IITRI’s bioaerosol generation and infection capability, along with increased capacity for NHPs in BSL-3/ABSL-3 increases our availability to conduct NHP studies across all our divisions.
Reach out to us today to learn how we can best support your program needs.
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