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

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

credit:


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.

Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Food and Drug Administration

Office:

Estimated Funding: $250,000


Who's Eligible


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
Full Announcement of RFA-FD-15-007 on NIH Guide for Grants and Contracts

Additional Information of Eligibility:
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.



Full Opportunity Web Address:


Contact:


Agency Email Description:


Agency Email:
lisa.ko@fda.hhs.gov

Date Posted:
2015-02-17

Application Due Date:
2015-04-27

Archive Date:
2015-05-27


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