DCTD In Vivo Preclinical Testing

体内临床前支持实验室-体内临床前支持小组通过体内潜在抗癌药物的测试为生物测试部门提供支持。提交给DTP的新制剂在中空纤维分析中进行评估，以评估其使用最少量的测试材料和最少数量的动物的体内活性潜力。然后在适当的啮齿动物肿瘤模型（例如，免疫缺陷小鼠的异种移植物或同基因小鼠的啮齿动物肿瘤）中测试在抗肿瘤作用之外，检查给药途径，剂量和剂量计划。除了功效研究，该小组还通过评估化合物对啮齿动物肿瘤生长的药效学（PD）效应，为0期和CBC计划提供支持。该小组是DTP抗癌药物开发工作，PD 0期标记物验证工作和CBC体内疗效评估途径的组成部分。

In Vivo Preclinical Support Laboratory - The In Vivo Preclinical Support group provides support to the Biological Testing Branch through its testing of potential anticancer agents in vivo. New agents submitted to the DTP are evaluated in the hollow fiber assay to assess their potential for in vivo activity using minimal amounts of test material as well as a minimal number of animals. Agents that are active in this assay are then tested in appropriate rodent tumor models (e.g., xenografts in immunodeficient mice or rodent tumors in syngeneic mice) where the route of administration, dose, and dose schedules are examined, in addition to the antitumor effect. Along with efficacy studies, this group provides support to the Phase 0 and CBC initiatives through evaluation of the pharmacodynamic (PD) effect of compounds on tumors growing in rodent species. This group is an integral part of the DTP anticancer drug development effort, the Phase 0 PD marker validation effort, and the CBC in vivo efficacy evaluation pathway. Compound Formulation & Compound Screening - The Compound Formulation & Compound Screening group provides support to the Biological Testing Branch through its preparation of test agents for assessment in the in vivo efficacy models including the hollow fiber and xenograft studies. This group maintains an inventory of test agents and accurately weighs and solubilizes the test material for testing. In addition, they determine the solubility of test agents in proposed vehicles as needed. This group also provides the technical support for the new combination drug screening effort undertaken in 2008. These assays provide in vitro efficacy data from studies in which a clinically approved agent is combined with a second clinically approved agent or an agent in clinical trials. These assays are conducted in 3 distinct cell lines using 3 dose levels of each test agent.