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.
| Kasturi, V K; Dearing, M P; Piscitelli, S C et al. (1998) Phase I study of a five-day dose schedule of 4-Ipomeanol in patients with non-small cell lung cancer. Clin Cancer Res 4:2095-102 |
