The FDA has announced a funding opportunity for a research project titled “Development of Clinically Relevant In Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis.” Two grants of $500,000 each are available.
The stated goal of the project is “to investigate if realistic physical mouth-throat (MT) models provide better predictability over pharmaceutical induction port assembly, for aerodynamic particle size distribution (APSD) characterization of orally inhaled drug products (OIDPs).”
The announcement explains, “Because there are different MT models proposed in the literature, in vivo predictability of several pre-screened MT models will be evaluated under different flow rate conditions, to select the optimal model(s). Upon successful completion, this research will provide a more realistic APSD characterization method that can be used as a pharmaceutical development tool in the early stages of OIDP development.”
Submissions can be made beginning May 1, 2014, and applications must be received by June 1, 2014.
Read the NIH funding opportunity announcement
