The contractor shall properly store, adequately test, and evaluate shelf life samples of investigational clinical drug formulations, including both injectable products and oral dosage forms, and report the results of such testing to the Pharmaceutical Resources Branch. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of various drug products under investigation, for determining appropriate expiration dates for the products, and to support NCI's Investigational New Drug Applications (INDs) files with the Food and Drug Administration (FDA). In addition, the project will require storage and inspection of reserve samples as defined by the FDA Current Good Manufacturing Practices regulations (CGMPs).

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM027721-001
Application #
2300392
Study Section
Project Start
1992-05-16
Project End
1997-04-15
Budget Start
1993-04-16
Budget End
1994-04-15
Support Year
Fiscal Year
1993
Total Cost
Indirect Cost
Name
University of Georgia
Department
Other Health Professions
Type
Schools of Pharmacy
DUNS #
City
Athens
State
GA
Country
United States
Zip Code
30602