The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) is seeking a contractor to supply analytical services for the analysis of bulk pharmaceutical substances and formulated drug products. Reports of these 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 (FDA) as part of the new Investigational New Drug (IND) filings for new antitumor and anti-AIDS 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. The contractors selected should be experienced in the analytical assessment of bulk pharmaceutical substances and clinical drug products and will be expected to have operational equipment and capabilities.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM027750-001
Application #
2300456
Study Section
Project Start
1992-06-01
Project End
1997-05-31
Budget Start
1993-06-01
Budget End
1994-05-31
Support Year
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Sri International
Department
Type
DUNS #
City
Menlo Park
State
CA
Country
United States
Zip Code
94025
Cheung, A P; Hallock, Y F; Vishnuvajjala, B R et al. (1998) Compatibility and stability of bryostatin 1 in infusion devices. Invest New Drugs 16:227-36
Nguyenle, T; Wang, E; Cheung, A P (1995) An investigation on the extraction and concentration of isoflavones in soy-based products. J Pharm Biomed Anal 14:221-32