Manufacture of Bulk Chemical and Bulk Pharmaceutical Ingredients

国家癌症研究所（NCI）癌症治疗和诊断部（DCTD）的发展治疗计划（DTP）负责开发具有抗癌活性的药物。这些药物通过许多机制，如NCI实验治疗学（NExT）、药物开发组（DDG）和快速访问NCI发现资源（兰德），来自各种同行评审来源。此外，开发项目可能来自临床成像剂和增强剂开发（DCIDE）计划、化学预防部门（DCP）计划、1型糖尿病RAID计划（T1 D-RAID）和NIH快速干预开发（NIH-RAID）计划。NCI的校内计划也是化合物的开发来源。 承包商提供服务，以多克和/或公斤规模制造各种选定的散装化合物。制备的散装材料将用于各种癌症适应症的临床前毒性研究、处方前和临床试验。承包商提交的技术报告可用于支持向美国食品药品监督管理局（FDA）提交的研究性新药申请（IND）。合同已被选为实现NCI癌症药物开发目标的工具。

The Developmental Therapeutic Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) conducts development of agents with anticancer activity. The agents arise from a variety of peer-reviewed sources via many mechanisms such as NCI Experimental Therapeutics (NExT), Drug Development Group (DDG), and Rapid Access to NCI Discovery Resources (RAND). In addition, development projects could arise from Development of Clinical Imaging Agents and Enhancers (DCIDE) program, Division of Chemoprevention (DCP) program, Type-1 Diabetes RAID program (T1D-RAID), and NIH Rapid Access to Intervention Development (NIH-RAID) program. The NCI intramural program has also been a source of compounds for development. The contractor provides services to manufacture a variety of the selected bulk compounds in multi-gram and/or kilogram scale. The prepared bulk material is to be used for preclinical toxicity studies, preformulation and clinical trials for the various cancer indications. Technical reports submitted by the contractors may be used to support Investigational New Drug Applications (IND) submitted to the US Food and Drug Administration (FDA). Contracts have been chosen as instruments to accomplish the goals of cancer drug development at the NCI.