INVESTIGATIONAL NEW OI DRUG TOXICOLOGY

新 OI 药物毒理学研究

• 批准号: 2295075
• 负责人: JAMES MACGREGOR
• 金额: $ 12.32万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-05-10 至 1996-05-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2295075
• 关键词: INVESTIGATIONAL; NEW; OI; DRUG; TOXICOLOGY

Current therapies to treat some of the opportunistic infections associated with the Acquired Immunodeficiency Syndrome (AIDS) either are toxic, marginally effective and/or inexpensive. In addition, there is no therapy recognized as effective for certain of the pathogens. Since these infections produce significant morbidity in patients with AIDS, the National Institute of Allergy and Infectious Diseases has funded several programs to facilitate discovery and development of novel therapies for the treatment of AIDS-related opportunistic infections. Due to the limited patient population affected by some of these opportunistic infections, the NIAID has funded a series of drug development contracts to complement the drug discovery process. Currently contracts are in place for chemical resynthesis, analytical chemistry/quality control and pharmaceutical manufacturing. The Government lacks the central resources to provide the health and safety assessment for these newly developed therapies as required by the Food and Drug Administration prior to initial testing in humans. This resource will provide the NIAID with testing capabilities to determine, in both rodents and larger animals, the toxicity of single and multiple doses of experimental therapies under conditions that will permit submission of the resulting data in support of an IND application for the new therapy. The contractor will carry out these studies in accord with FDA's Good Laboratory Practice regulations. The contractor will also have the capability to carry out studies in the areas of specific organ toxicity, dose ranging toxicity studies, pharmacokinetics, etc., to assist the sponsor in addressing key toxicity questions in the development of a compound.

目前治疗一些相关机会性感染的疗法 患有获得性免疫缺陷综合症（艾滋病）的药物要么是有毒的， 边际有效和/或便宜。 另外，没有治疗方法 被认为对某些病原体有效。 由于这些 感染导致艾滋病患者显着发病， 国家过敏和传染病研究所资助了多项 促进新疗法的发现和开发的计划 治疗艾滋病相关的机会性感染。 由于条件有限 受其中一些机会性感染影响的患者群体 NIAID 资助了一系列药物开发合同，以补充 药物发现过程。 目前化学品合同已经到位 再合成、分析化学/质量控制和制药 制造业。 政府缺乏中央资源来提供 对这些新开发的疗法的健康和安全评估 美国食品和药物管理局在初步测试之前要求 人类。 该资源将为 NIAID 提供测试能力 确定啮齿动物和大型动物的毒性 在允许的条件下进行多剂量的实验性治疗 提交结果数据以支持 IND 申请 新疗法。 承包商将根据以下规定开展这些研究 FDA 的良好实验室规范法规。 承包商还将拥有 在特定器官领域进行研究的能力 毒性、剂量范围毒性研究、药代动力学等，以协助 申办者解决开发中的关键毒性问题 化合物。