exposure atmosphere generation and characterization

Test Article Aerosol Generation Methods

The development of methods for exposure atmosphere generation with a particle size range allowing lung deposition is the first step in any inhalation toxicology study. Preliminary method development activities can include:

• 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)

Our expert staff has decades of experience working with a wide range of chemicals and drugs with complex properties, including:

• Gasses or vapors
• Liquids and suspensions
• Powders, fibers or nanoparticles
• Metered dose inhaler formulations and devices
• Electronic cigarettes or tobacco product smoke

The IITRI Advantage

• 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
• Experience handling difficult materials including solids, liquids, and gasses