TAS::75 0862::ANALYTICAL CHEMISTRY SUPPORT OPTIONAL STUDY 6

该项目的目标是为国家毒理学计划(NTP)的危险识别活动提供支持，旨在预防因环境暴露于化学或物理制剂而导致的疾病或不良影响。毒理学测试是公共卫生研究的一个重要方面，因为它用于识别对人类健康有害的化学物质。在毒理学研究中，必须进行适当的化学分析，以确保试验物种暴露在指定剂量浓度的指定化学品中。这份合同有助于毒理学研究提供癌症风险增加的证据以及其他毒理学结果，方法是提供所研究的化学物质的特性、所用剂量水平的确认以及内部剂量测定。这些信息对毒理学测试的评估和对试验物种中研究化学物质的潜在毒理学做出合理、科学的结论至关重要，并最终支持国家毒理学计划和其他联邦机构的风险评估工作。根据本合同提供的内部剂量信息，可以对人体进行外推，以便公众能够充分了解暴露于所研究的化学品中的危险因素。 在2011财年期间，正在进行多项任务，以支持NTP艾滋病研究和测试方案。在本报告所述期间，化学支助承包商采购并开始对4种新的艾滋病疗法进行全面鉴定。采用超高效液相色谱、气相色谱和元素分析等方法对恩曲他滨、洛匹那韦、利托那韦和替诺福韦的纯度进行了鉴定。此外，化学承包商完成了所有储存的大量甲磺酸奈非那韦的整合以及相关的鉴定工作。

The goal of this project is to provide support of National Toxicology Program (NTP) hazard identification activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical or physical agents. Toxicology testing is an important aspect of public health research in that it serves to identify chemicals that are hazardous to human health. Proper chemical analyses are required to ensure that, in toxicology studies, the test species are exposed to the prescribed chemicals at the specified dose concentrations. This contract contributes to the ability of toxicology studies to provide evidence of heightened cancer risk along with other toxicological outcomes, by providing characterization of the chemicals studied, confirmation of the dose levels administered, and internal dose determinations. This information is critical to evaluation of toxicology tests and development of sound, scientific conclusions about the potential toxicology of the study chemical in the test species and ultimately supports the risk assessment efforts of National Toxicology Program and other federal agencies. With internal dose information provided by this contract, extrapolations to humans can be made so that the public can be adequately informed about risk factors arising from exposure to studied chemicals During FY11 more than multiple tasks were in-progress in support of NTP AIDS research and testing protocols. The chemistry support contractor procured and initiated the comprehensive characterization of 4 new AIDS therapeutics during the reporting period. UPLC, gas chromatography, and elemental analysis were used to assess the purity of emtricitabine, lopinavir, ritonavir, and tenofovir. In addition, the chemistry contractor completed consolidation of all stored lots of nelfinavir mesylate as well as the associated characterization effort.