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）的危害识别活动提供支持，这些活动旨在预防因环境暴露于化学或物理制剂而引起的疾病或不良影响。毒理学测试是公共卫生研究的一个重要方面，因为它有助于确定对人类健康有害的化学品。需要进行适当的化学分析，以确保在毒理学研究中，试验种属暴露于规定剂量浓度的规定化学品。该合同有助于毒理学研究的能力，提供癌症风险增加的证据沿着其他毒理学结果，通过提供所研究的化学品的特征，确认给药剂量水平，以及内部剂量测定。该信息对于评价毒理学试验和得出关于试验种属中研究化学品潜在毒理学的合理科学结论至关重要，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，可以对人类进行外推，以便公众能够充分了解暴露于所研究的化学品所产生的风险因素 在2011财政年度，正在进行多项任务，以支持国家结核病规划署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了4种新的艾滋病疗法，并开始进行全面定性。使用UPLC、气相色谱和元素分析评估恩曲他滨、洛匹那韦、利托那韦和替诺福韦的纯度。此外，化学承包商完成了甲磺酸奈非那韦所有储存批次的合并以及相关表征工作。

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.