This contractor will supply the Pharmaceutical Resources Branch, Developmental Therapeutics Program, Division of Cancer Treatment, National Cancer Institute with 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 U.S. Food and Drug Administration (FDA) as part of the new Investigational New Drug (IND) filings. 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.
| Hettiarachchi, K; Cheung, A P (1993) Quantitative capillary electrophoresis and its application to the polyanionic quinobene. J Pharm Biomed Anal 11:1251-9 |
| Cheung, A P; Nguyenle, T; Hettiarachchi, K (1993) Liquid chromatography and capillary electrophoresis analysis of polyanionic quinobene. J Pharm Biomed Anal 11:1261-7 |
