The objective of this contract effort is to properly store, adequately test and evaluate shelf life samples of investigational clinical drug formulations, including both injectable products and oral dosage forms, and report the results of such testing to the NCI. These reports will be used for providing NCI and its investigators with information regarding the proper storage and handling of the various drug products under investigation, for determining appropriate expiration dates for the products, and in support of the NCI's Investigational New Drug Applications (INDs) filed with the Food and Drug Administration (FDA). In addition, the project will require storage and inspection of reserve samples as defined by the FDA Current Good Manufacturing Practices regulations (CGMPs)
| Toledo, M M; Cadwallader, D E; Trissel, L A et al. (1989) Stability of pibenzimol hydrochloride in commonly used infusion solutions and after filtration. Am J Hosp Pharm 46:2043-6 |
