STARTING OFF ON THE RIGHT FOOT

Our inhalation services include preliminary method development activities as the necessary first step for inhalation toxicology studies. The selection and characterization of the test atmosphere to be realistic and extensively measured for the specific drug type is of utmost importance considering the complexity and higher cost of inhalation studies compared with other routes of administration. 

Our expert staff have decades of experience working with many types of complex chemicals and drugs such as gasses, vapors, liquids, suspensions, powders, fibers, and nanoparticles. We also have capabilities for metered dose inhaler (MDI) formulations and devices, as well as support for e-cig and tobacco product studies.

Exposure atmosphere activities often include the following:

  • Development and optimization of methods to generate the test atmosphere, including a determination of the Maximum Feasible Concentration (MFC).
  • Characterization of test atmosphere, including test article concentration; particle size distribution (Mass Median Aerodynamic Diameter and Geometric Standard Deviation), spatial uniformity and temporal stability evaluations that encompass the maximum intended duration of in vivo exposure. Note: Exposure characterization is limited to gravimetric filter if the study needs to be conducted in an ABSL3. Collection of impinger samples and chemical analysis can also be performed.
  • Technology transfer of the method for quantitative analysis of test article in exposure system filters (HPLC; to permit characterization of exposure levels).

 

PATH TO THE FINISH LINE

  • Over 40 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
  • Multiple inhalation exposure methods including nose only, whole body, oronasal, API-sparing dry powder, and liquid intratracheal administration
  • Experience handling difficult materials including solids, liquids, and gasses
  • Support for 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.

 

 

Have a promising drug candidate? Contact us today to discuss your inhalation toxicology program needs!