Food and Drug Administration

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.

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