Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide

Post Date

July 19th 2013

Application Due Date

August 15th 2013

The application receipt/due date is August 15, 2013 by 11:59PM Eastern time.

Funding Opportunity Number

RFA--FD-13-035

CFDA Number(s)

93.103

Funding Instrument Type(s)

Grant

Funding Activity Categories

Consumer Protection
Food and Nutrition

Number of Awards

3

Eligibility Categories

Public and State Controlled Institutions of Higher Education

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $0 - $100000

Grant Description

This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will allow collecting in vivo data when furosemide (the model drug) will be given with milk, baby formula and Ensure Plus╙ to healthy adults. The suitability of the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug will be determined.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Oluyemisi (Yemisi) Akinneye
  Grants Management Specialist
  Phone 3018270079

• Agency Mailing Address:

  Oluyemisi.Akinneye@fda.hhs.gov

• Agency Email Address:

  Oluyemisi.Akinneye@fda.hhs.gov

• More Information:

  NIH Guide for Grants and Contracts