INVESTIGATIONAL NEW OI DRUG TOXICOLOGY

目前治疗一些机会性感染的治疗方法 获得性免疫缺陷综合征（AIDS）的患者要么是有毒的， 勉强有效和/或便宜。 此外，没有任何治疗方法 对某些病原体有效。 由于这些 艾滋病感染者的发病率很高， 国家过敏和传染病研究所资助了几个 促进发现和开发新疗法的计划， 治疗艾滋病相关的机会性感染。 由于有限的 受这些机会性感染影响的患者人群， 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， 对这些新开发的疗法进行健康和安全评估， 食品和药物管理局要求在初始测试之前， 人类 该资源将为NIAID提供测试能力， 在啮齿动物和大型动物中，确定单一和 在允许的条件下进行多剂量的实验性治疗 提交结果数据以支持IND申请， 新疗法 承包商将根据雅阁进行这些研究， FDA的药物非临床研究质量管理规范。 承包商还将 在具体机构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，协助 申办者在解决开发中的关键毒性问题时， 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.