The objective of this contract effort is to 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 NCI. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of the various drug products under investigation, for determining appropriate expiration dates for the products, and in support of the NCI's Investigational New Drug Applications (INDs) filed 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 #
N01CM073712-002
Application #
3614845
Study Section
Project Start
1987-08-16
Project End
1992-08-15
Budget Start
1989-08-16
Budget End
1990-08-15
Support Year
Fiscal Year
1989
Total Cost
Indirect Cost
Name
University of Georgia
Department
Type
Schools of Pharmacy
DUNS #
City
Athens
State
GA
Country
United States
Zip Code
30602
Toledo, M M; Cadwallader, D E; Trissel, L A et al. (1989) Stability of pibenzimol hydrochloride in commonly used infusion solutions and after filtration. Am J Hosp Pharm 46:2043-6