INVESTIGATIONAL NEW OI DRUG TOXICOLOGY

目前用于治疗某些机会性感染的治疗方法 获得性免疫缺陷综合症(艾滋病)要么是有毒的， 略微有效和/或便宜。此外，也没有治疗方法。 公认对某些病原体有效。因为这些 感染在艾滋病患者中产生显著的发病率， 国家过敏和传染病研究所已经资助了几个 促进发现和开发新的治疗方法的计划 艾滋病相关机会性感染的治疗。由于有限的原因 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。目前已经签订了化学品合同。 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，无法提供 对这些新开发的治疗方法进行健康和安全评估 食品和药物管理局要求在以下时间进行初步测试 人类。该资源将为NIAID提供测试能力，以 在啮齿动物和更大的动物中，确定单一和 在允许的条件下进行多剂量的实验性治疗 提交所产生的数据，以支持IND申请 新疗法。承包商将按照以下规定进行这些研究 FDA的《良好实验室操作规程》。承包商还将拥有 在特定器官领域开展研究的能力 毒性，剂量范围毒性研究，药代动力学等，以协助 赞助商在解决在开发一种 化合物。

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.