Dissolution Methods for Long-acting Periodontal Drug Products (U01)

Post Date

February 17th 2015

Application Due Date

April 27th 2015

Funding Opportunity Number

RFA-FD-15-007

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

2

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $125000

Grant Description

There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to develop a bio-relevant dissolution method for a long-acting periodontal dosage form and to identify the drug product's key physicochemical attributes that affect the drug dissolution behavior and bioavailability. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting periodontal drug products.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist
  

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-15-007 on NIH Guide for Grants and Contracts