The contractor shall analyze bulk pharmaceutical substances and formulated drug products for anti-cancer agents. Reports of the analyses will be used as a basis for assessing the suitability of these materials for use for screening, pharmacological studies, toxicological studies, formulation studies or for clinical trials. Data provided in these analytical reports will be supplied to the Food and Drug Administration as part of the new IND filings for new anti-cancer agents. Historical summaries of the data are used in preparing specifications for the various bulk pharmaceutical substances. These specifications are used in procurement actions as well as for the routine quality control of these materials.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM073714-004
Application #
3614864
Study Section
Project Start
1987-06-01
Project End
1992-05-31
Budget Start
1990-06-01
Budget End
1991-05-31
Support Year
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Research Triangle Institute
Department
Type
DUNS #
131606022
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27709
Duafala, M E; Kleinberg, M L; Nacov, C et al. (1990) Stability of morphine sulfate in infusion devices and containers for intravenous administration. Am J Hosp Pharm 47:143-6
Kleinberg, M L; Duafala, M E; Nacov, C et al. (1990) Stability of heroin hydrochloride in infusion devices and containers for intravenous administration. Am J Hosp Pharm 47:377-81