ANTI-CANCER AND ANTI-AIDS CHEMICALS AND FORMULATIONS

抗癌和抗艾滋病化学品和制剂

• 批准号: 2300460
• 负责人: A CHEUNG
• 金额: $ 17.6万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-06-01 至 1997-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300460
• 关键词: ANTI; CANCER; AIDS; CHEMICALS; FORMULATIONS

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.

制药资源分支（PRB），发育疗法 计划（DTP），癌症治疗部（DCT），国家癌症 研究所（NCI）正在寻求承包商来为 大量药物和配方药物的分析 产品。 这些分析的报告将被用作评估的基础 这些材料用于筛查的适用性，药理 研究，毒理学研究，制剂研究或临床 试验。 这些分析报告中提供的数据将提供给 食品和药物管理局（FDA）作为新调查的一部分 药物（IND）新抗肿瘤和抗辅助药物的申请。 历史 数据的摘要用于准备各种规范 散装药物。 这些规格用于 采购行动以及这些的常规质量控制 材料。 选定的承包商应在 大量药物和临床药物的分析评估 产品，并有望拥有运营设备和 功能。