The Contractor shall provide analytical services for the analysis of bulk pharmaceutical substances and formulated drug products. Reports of analytical testing on bulk drugs and dosage forms will be used as a basis for assessing the suitability of these materials for use in screening, pharmacological studies, toxicological studies, formulation studies, or for clinical trials. These data will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for new antitumor and anti-AIDS agents. Historical summaries of the data will be used in procurement actions as well as for the routine quality control of these materials. In addition, solubility and stability data will be developed, and selected assay methods will be adapted for the quantitation of drug in plasma. These data will be provided to other contract projects to facilitate formulation development, and to aid in the analytical aspects of pharmacology and, toxicological testing.
