Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)

Archived

Food and Drug Administration

Description

Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will explore in vivo performance of furosemide in vivo in an environment similar to that seen in pediatric patients Furosemide will be given with milk, baby formula and Ensure Plus™ to healthy adults. The studies will be designed with emphasis on the absorption phase and the changes that may be detected during the first 4 to 6 hours after dosing.

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

Lisa Ko <br/>Grants Management Specialist <br/>
lisa.ko@fda.hhs.gov

Key dates & funding
  • PostedJun 10, 2014
  • ClosesJul 15, 2014
  • Award ceiling$100,000
  • Program funding$100,000
  • Expected awards1
  • CFDA93.103

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