Lovelace Biomedical has been a world leader in the area of respiratory drug delivery, respiratory physiology, respiratory toxicology and complex respiratory testing for nearly 60 years.  This experience provides clients with a unique merger of experience and ability to meet current regulatory needs for respiratory drug development.  Whether the project is an NCE, a 505(b)2/generic or working with an excipient towards a DMF Lovelace Biomedical provides you with the experience, and proven track record of success to be your partner in drug development. 

Preclinical Respiratory Research – Lovelace Biomedical has been recognized as a world leader in conducting respiratory pharmacology and toxicology studies for more than 40 years. Expertise includes the development of new respiratory therapies, new animal models of respiratory diseases, the conduct of IND and NDA enabling toxicology studies and the merger of respiratory models/toxicology with larger programs. 

Capabilities include:

  • Research expertise and pharmacology models in asthma, COPD, cancer, fibrosis, infectious disease and inflammation
  • Low test article consumption exposure systems for management of test article use
  • Nose-only, whole-body and head only exposures
  • Exposure systems for multiple species, including rodent, swine, canine and nonhuman primate
  • Inhalation formulation for dry powder, nebulizer and metered dose inhalers
  • Inhalation under high-containment conditions for toxic agents
  • Inhalation of radiolabeled materials
  • Tobacco smoke and alternative tobacco product inhalation systems

Inhalation Toxicology

Lovelace Biomedical conducts a full range of Good Laboratory Practice (GLP) and Non-GLP inhalation bioassays and 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.

Inhalation Toxicology Fact Sheet

Key Capabilities:

  • 30-year history of compliance with national and international GLP regulations for pharmaceutical and chemistry industry partners
  • IND-, NDA-, BLA-enabling safety programs
  • Novel techniques for conserving test articles during aerosolization and delivery
  • Supporting nebulizers, metered dose inhalers, dry powder inhalers and unique aerosol generation systems
  • Novel exposure techniques for developmental work and pilot studies, including measurement and control of respiration in all species, simulation of human oral dosing using dogs and primates, and exposure by intratracheal instillation or via bronchoscopy
  • Wide range of dosimetric (including tissue-specific compound analysis),
    toxicokinetic, clinical, physiological, and genetic assays
  • Exposures to gases, vapors, fibrous and nonfibrous particles, and to engine exhaust, cigarette smoke, and other actual or synthesized complex mixtures
  • Generation and exposure to radiolabeled and radioactive materials
  • Full histopathology, immunohistochemistry, and morphometric capability
  • AAALAC-accredited animal facilities
  • Approved waste streams for hazardous materials
  • Confidential, proprietary, and intellectual property agreements
  • Collaboration with customer’s in-house investigations