Preclinical Inhalation Toxicology – Lovelace has been performing large- and small-animal toxicology studies ranging from non-GLP investigational toxicology to GLP regulatory toxicology for more than 70 years. We work with sponsors to develop customized study designs including a range of toxicokinetic, clinical, physiological, immunological, and genetic endpoints.
70+Years Inhalation Toxicology Experience
Custom Study Designs & Specialty Routes Available
Lovelace Biomedical conducts a full range of Good Laboratory Practice (GLP) and Non-GLP inhalation studies. We are known worldwide for our storied and long history in the field of inhalation toxicology. We integrate quality, leading-edge expertise in generation and characterization of exposure atmospheres, exposure technology, dosimetry, and evaluation of health outcomes, as needed to quickly meet study goals. Lovelace’s large Inhalation Toxicology facility has capabilities and capacity to conduct single or repeated, nose-only or whole-body inhalation exposures of all laboratory species. Exposures range from individual animals for preliminary investigations to large-scale carcinogenicity bioassays.
Lovelace Biomedical has an extensive record of successfully designing and executing regulatory toxicology studies for submission to U.S. and European regulatory bodies, including the FDA and EMEA, with capabilities to address regulations of other countries, as well. Our toxicology, bioanalytical, pathology and genetic toxicology capabilities are combined in a centralized facility, allowing us to efficiently conduct an array of IND-enabling studies.
Our scientists work closely with sponsors to design programs that achieve their goals while minimizing timeline and investment. Beginning with non-GLP investigational toxicology and dose-range finding studies, we focus on generating the data needed to support regulatory submissions. Our team is recognized for its excellence in tackling the many challenges of highly innovative drug classes and new delivery mechanisms, while also bringing the experience and foresight to proactively address the many unseen complexities of seemingly routine programs.
- IND, NDA, BLA – enabling safety programs
- Histopathology, immunohistochemistry, morphometric capability
- Standard Routes: Nose, head, whole body
- Supporting nebulizers, metered dose inhalers, dry powder, unique aerosol systems
- Exposure to gases, vapors, fibrous, non-fibrous particles, exhausts, smoke, & other complex mixtures
- Non-human primate
- Gottingen, Yucatan or Yorkshire swine
- Guinea pig
Routes of Administration
- Standard routes: IV, IM, IP, SC, PO, Dermal
- Inhalation (nose-only, head-only or whole body)
- Arterial (hepatic artery, carotid artery or femoral artery)
- Intravenous infusion: Bolus, intermittent, continuous
- Intracerebral, intraventricular or intrathecal