Food and Drug Administration

Description

Locally-acting orally inhaled drug products (OIDPs) treat various pulmonary diseases by targeting relevant lung tissue via aerosolized medicine. Regional deposition models are useful for understanding the in vivo performance of OIDPs but require comparator data to support their use for product development purposes. In vivo imaging studies of regional deposition, using techniques such as gamma scintigraphy or single photon emission computed tomography (SPECT) /computed tomography (CT) can provide comparator data for regional deposition models, but the data collected may not be ideally suited to comparison with model predictions. For example, gamma scintigraphy studies produce two-dimensional region specific data while model predictions produce three-dimensional lung generation-level information. The purpose of this funding opportunity announcement is to support the conduct of an in vivo imaging study that uses gamma scintigraphy or SPECT/CT techniques to measure regional lung deposition in human subjects following administration of at least one OIDP with data analysis procedures that are optimized to facilitate a direct comparison with model predictions of branch-level deposition, thereby supporting model validation.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov