COLLECTION OF BIOLOGICAL SAMPLES FOR LAB ASSAY DEVELOPMENT

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项工作不是一个标准的研究方案。这是IRB批准的一种收集人类生物样本的方法，包括血液、尿液、粪便、精液、唾液或母乳，用于开发药物和生化标志物的分析，以支持预期的未来临床研究或正在进行的研究，并评估资助申请的可行性。具体目的：为了收集必要的样品，我们需要开发各种实验室分析。背景和意义：为了在特定的感兴趣的生物样品中验证测定方法，许多测定方法的开发都需要生物样品。这些分析将帮助我们证明分析的可行性和分析的性能特征，作为规划临床药物研究的必要准备步骤。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This work is not a standard research protocol. It is an IRB approved method of collecting human biological samples including blood, urine, stool, semen, saliva or breast milk to use in the development of assays of drugs and biochemical markers necessary to support anticipated future clinical studies or ongoing studies and to assess grant application feasibility. SPECIFIC AIMS: To collect the necessary samples we need to develop various lab assays. BACKGROUND AND SIGNIFICANCE: Biologic samples are required for the development of many assays to validate the assay method in the specific biologic sample of interest. These assays will assist us in demonstrating feasibility of the assay and performance characteristics of the assay as essential preparatory steps for planning clinical drug studies.