ANALYTICAL CHEMISTRY OF CHEMICALS AND PHARMACEUTICALS

获得性免疫缺陷综合症（艾滋病）司和 美国国立卫生研究院微生物学和传染病项目 过敏和传染病积极参与计划，以： 对传染病过程进行基本调查， 发现新的治疗方法来治疗这些条件，通过 国家合作药物发现小组机制和筛选 程序. 这些疗法针对各种各样的传染性疾病， 疾病，包括由HIV、巨细胞病毒、疱疹 单纯性，肺孢子虫肺炎，白色念珠菌，鸟分枝杆菌 一些但不是所有的NIAID资助的药物发现 机制有能力和能力执行所要求的 研究将表现出活性的化学品转化为预测性的 体外试验系统或动物模型制成药物剂型 以足够的规模生产，以允许I期和II期临床试验 物质的评价。 这一举措提供了分析 化学/质量控制能力，以验证身份和评估 评价前化学品的纯度：体内动物 模型、毒理学研究、药物剂型和临床 审判 此外，承包者将评估溶解度， 这些试剂的稳定性和推荐的适当程序 在体内功效模型评价期间对这些化合物的处理 和毒性。 分配系数、pKa和Ph的测定 与稳定性曲线，将用于获得初步 关于一种新化合物的信息，可以预测生物学行为。 承包商还将分析最终剂型，并评估其 随着时间的推移稳定。 估计血液中药物的方法， 尿液也将被显影。

The Division of Acquired Immune Deficiency Syndrome (AIDS) and the Microbiology and Infectious Disease Program of the National Institute of Allergy and Infectious Diseases are actively engaged in programs to: carry out basic investigations of the infectious disease process, and discover novel therapeutic approaches to treat these conditions via the National Cooperative Drug Discovery Group mechanism and screening programs. These therapies are directed at a wide variety of infectious diseases including those produced by HIV, cytomegalovirus, Herpes simplex, Pneumocystis pneumonia, Candida albicans, Mycobacterium avium complex, etc. Some but not all of the NIAID funded drug discovery mechanisms have the capability and capacity to carry out the required studies to convert chemicals exhibiting activity in a predictive in vitro test system or animal model into a pharmaceutical dosage form manufactured on sufficient scale to permit phase I and II clinical evaluation of the substance. This initiative provides analytical chemistry/quality control capability to verify the identity and assess the purity of the chemicals prior to evaluation in: in vivo animal models, toxicology studies, pharmaceutical dosage forms, and clinical trials. In addition, the contractor will evaluate the solubility and stability of these agent and recommend procedures for the appropriate handling of these compounds during evaluation in vivo models of efficacy and toxicity. Determinations of partition coefficients, pKa's, and Ph versus stability profiles, will be used to obtain preliminary information on a new compound that may predict for biologic behavior. The contractor will also assay the final dosage form and assess its stability over time. Methodology to estimate the drug in blood and urine also will be developed.