Synthesis of Bulk Drugs and Chemicals for Preclinical and Clinical Studies

开发治疗计划(DTP)，癌症治疗和诊断部(DCTD)，国家癌症研究所(NCI)进行具有抗癌活性的药物的开发。这些代理来自各种同行评审的来源，通过许多机制，如药物开发小组(DDG)、快速访问干预开发(RAID)和快速访问NCI发现资源(RAND)。此外，开发项目可能来自临床显像剂和增强剂开发(DCide)计划、化学预防部门(DCP)计划、1型糖尿病RAID计划(T1D-RAID)和NIH-RAID计划。NCI内部计划也是开发化合物的来源。 承包商提供服务，以制造多种选定的多克和/或千克规模的散装化合物。制备的原料药将用于各种癌症适应症的临床前毒性研究、配方前和临床试验。承包商提交的技术报告可用于支持向美国食品和药物管理局(FDA)提交的调查性新药申请(IND)。合同已被选为实现NCI抗癌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 Drug Development Group (DDG), Rapid Access to Intervention Development (RAID), 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-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.