OpportunityTitle: Dissolution Methods for Long-acting Periodontal Drug Products (U01)
AdditionalInformationOnEligibility: 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.
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&apos;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.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist &lt;br/&gt;