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.
