CORE--PHARMACOLOGY LABORATORY

美国加州大学旧金山分校药理学核心实验室 弗朗西斯科将负责药物浓度测量， 支持药物药理学研究的药代动力学分析 用于治疗HIV感染和相关的机会性 感染. 该实验室将作为ACTG的中心设施 药物和代谢物浓度的常规分析试验 生物液体（如齐多夫定），并将负责 开发和实施新的化学或生物测定方法， 治疗剂。 此外，实验室人员将提供 研究设计和分析咨询，包括 药代动力学和药效学分析。 核心药理学实验室单位一直是核心实验室设施 为ACTG工作了五年 本实验室的工作人员是 在化学和生物测定开发和常规药物方面经验丰富 水平测量已经开发或实施了许多分析， 药剂，例如齐多夫定（ZDV）、GZDV、膦甲酸、AzdU、GM-CSF、氨苯砜， 甲氧苄啶和磺胺甲恶唑。 目前使用的测定方法 包括HPLC、气相色谱、ELISA、放射免疫测定和荧光 极化 所有新药试验开发将由 经验丰富的研究化学家和工作人员的研究助理进行 用于测量细胞内ZDV及其 在单核细胞/巨噬细胞和淋巴细胞组分中磷酸化的补体。 用于药代动力学分析的程序包括房室模型和 使用微机程序（如PC NONLINR）的非房室方法 关于SIPHARR 对于基于人群的药代动力学研究， 在药效学研究中，将使用NONMEM和Emax建模程序。

The Core Pharmacology Laboratory Unit of the University of California, San Francisco will be responsible for drug concentration measurements and pharmacokinetic analysis to support pharmacologic investigations of drugs used in the treatment of HIV infection and associated opportunistic infections. The laboratory will function as a central facility for ACTG trials for the routine analysis of drug and metabolite concentrations in biological fluids (e.g. zidovudine) and will be responsible for the development and implementation of chemical or biological assays for new therapeutic agents. In addition, laboratory personnel will provide consultation on study design and analysis including performance of pharmacokinetic and pharmacodynamic analysis. The Core Pharmacology Laboratory Unit has been a core laboratory facility for the ACTG for the last 5 years. Personnel of this laboratory are experienced in chemical and biological assay development and routine drug level measurement having developed or implemented assays for numerous agents, e.g. zidovudine (ZDV), GZDV, foscarnet, AzdU, GM-CSF, dapsone, trimethoprim, and sulfamethoxazole. Assay methodologies currently in use include HPLC, gas chromatography, ELISA, radioimmunoassay, and fluorescent polarization. All new drug assay development will be carried out by experienced research chemists and performed by staff research associates assay development for measurement of intracellular ZDV and its phosphorylated anabolites in monocyte/macrophage and lymphocyte fractions. Procedures utilized for pharmacokinetic analysis include compartmental and non-compartmental methods using microcomputer programs such as PC NONLINR and SIPHARR. For population based pharmacokinetic studies and pharmacodynamic studies, NONMEM and Emax modeling procedures will be used.