CORE--CHEMOTHERAPY AND TOXICOLOGY

核心——化疗与毒理学

• 批准号: 6563809
• 负责人: WILLIAM R WAUD
• 金额: $ 22.84万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-02-01 至 2003-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6563809
• 关键词: antineoplastics; biological models; biomedical facility; cell line; chemical structure function; combination cancer therapy; drug administration rate /duration; drug resistance; drug screening /evaluation; high throughput technology; histology; laboratory mouse; neoplasm /cancer chemotherapy; neoplasm /cancer surgery; neoplasm /cancer transplantation; nonhuman therapy evaluation; nucleoside analog; pharmacokinetics; statistics /biometry; tissue /cell culture; toxicology; xenotransplantation

APPLICANT'S DESCRIPTION: (provided by Applicant) This core component is composed of laboratory facilities, equipment, and services that will be shared by the four projects of the proposed program. The core is service-oriented in concept. Its objective will be to provide in a timely, efficient, and cost-effective manner the evaluation of the antitumor activity of candidate drugs that may be at various stages of development in the proposed program. Evaluations may range from initial screening (cytotoxicity compared to relevant standard agents) to detailed evaluations in support of an IND application (e.g., dose and treatment schedule optimization). Evaluations will be conducted in an array of in vitro and in vivo models configured to provided a standardized approach to the development of agents with unknown activity but flexible enough to provide additional guidance in the selection of in vivo models (human tumor xenografts) for detailed evaluation of drug activity. These studies may be complemented by evaluations in conventional murine tumor models. This approach, although not exclusive, emphasizes discovery and development of agents active against solid tumors. Data will be presented in terms of comparative IC50 values from in vitro studies and clinically relevant endpoints (e.g., cures, regressions, or prolonged time to treatment failure) from in vivo studies. Dose-response relationships will be assessed in all studies. Use of these data in drug development decision making will be a cooperative effort among the core component leader, the individual project leaders, and the program PI.

申请人的描述：（由申请人提供）该核心组件是 由共享的实验室设施、设备和服务组成 由拟议计划的四个项目组成。 核心是面向服务 概念。 其目标是提供及时、高效、 以经济高效的方式评估候选者的抗肿瘤活性 拟议计划中可能处于不同开发阶段的药物。 评估范围可能包括初步筛选（细胞毒性与 相关标准药物）到支持 IND 的详细评估 应用（例如剂量和治疗方案优化）。 评价 将在一系列体外和体内模型中进行，这些模型配置为 为未知代理的开发提供了标准化方法 活动但足够灵活，可以在选择时提供额外的指导 用于详细评估药物的体内模型（人类肿瘤异种移植物） 活动。 这些研究可以通过传统的评估来补充 小鼠肿瘤模型。 这种方法虽然不是排他性的，但强调 发现和开发活性抗实体瘤的药物。 数据将是 以体外研究的比较 IC50 值和 临床相关终点（例如治愈、消退或延长治疗时间） 治疗失败）来自体内研究。 剂量-反应关系将是 在所有研究中进行评估。 在药物开发决策中使用这些数据 制作将是核心组件领导者、 个人项目负责人以及项目 PI。