Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies

用于临床前和临床研究的散装化学品和散装药物成分的制造

• 批准号: 9915787
• 负责人: SERGIY DENYSENKO
• 金额: $ 67.41万
• 依托单位: ALCHEM LABORATORIES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2019-06-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9915787
• 关键词: Chemicals; Clinical; Clinical Research; Clinical Trials; Developmental Therapeutics Program; Human; Investigational Therapies; Malignant Neoplasms; Manufactured Supplies; National Cancer Institute; Pharmaceutical Preparations; Pharmacologic Substance; Research Personnel; Therapeutic Agents; drug discovery; novel therapeutics; preclinical study; programs

The Developmental Therapeutics Program (DTP) at the National Cancer Institute (NCI) supports the NCI's Experimental Therapeutics (NExT) program to facilitate the transition of novel drug discoveries into clinical trials of new cancer therapeutic agents. One of essential parts of the program involves the manufacture and supply of bulk chemicals/drugs that are prepared under the current Good Manufacturing Practice (c-GMP). The bulk drugs will be used to support pre-clinical studies and to prepare clinical products that are necessary to support human clinical trials under the NCI sponsorship or investigator initiated INDs.

国家癌症研究所(NCI)的发展治疗计划(DTP)支持NCI的 促进新药发现转化为临床试验的实验治疗(NEXT)计划 新的癌症治疗药物。该计划的基本部分之一涉及散装货物的制造和供应 根据现行良好制造规范(c-GMP)制备的化学品/药物。散装药品将是 用于支持临床前研究和制备支持人体临床试验所必需的临床产品 在NCI的赞助下，或研究人员发起了IND。