INVESTIGATIONAL NEW OI DRUG TOXICOLOGY

新 OI 药物毒理学研究

• 批准号: 2295067
• 负责人: JAMES MACGREGOR
• 金额: $ 62.18万
• 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/2295067
• 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.

当前治疗一些相关机会感染的疗法 与获得的免疫缺陷综合征（AIDS）有毒， 略有效和/或便宜。 另外，没有治疗 被认为对某些病原体有效。 由于这些 感染在AIDS患者中产生明显的发病率， 美国国家过敏和传染病研究所已资助了几项 促进发现和开发新型疗法的计划 治疗与艾滋病相关的机会感染。 由于有限 受这些机会感染中的某些影响的患者群体， NIAID资助了一系列药物开发合同，以补充 药物发现过程。 目前的化学合同 重新合成，分析化学/质量控制和药物 制造业。 政府缺乏提供的中央资源来提供 这些新开发的疗法的健康与安全评估 食品和药物管理局要求在初次测试之前 人类。 该资源将为NIAID提供测试功能 在啮齿动物和较大的动物中，都确定单一和 在条件下，多剂量的实验疗法将允许 提交结果数据，以支持IND应用程序 新疗法。 承包商将按照 FDA的良好实验室实践法规。 承包商也将 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 在解决发展中的关键毒性问题方面的赞助商 化合物。