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

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,

credit: Flickr


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.

Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food & Drug Administration

Estimated Funding: $250,000


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
NIH Guide for Grants and Contracts

Additional Information of Eligibility:
Not Available

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-13-035.html

Contact:
Oluyemisi (Yemisi) AkinneyeGrants Management SpecialistPhone 3018270079

Agency Email Description:
Oluyemisi.Akinneye@fda.hhs.gov

Agency Email:
Oluyemisi.Akinneye@fda.hhs.gov

Date Posted:
2013-07-19

Application Due Date:
2013-08-15

Archive Date:
2013-09-14



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