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.
