COLLECTION OF BIOLOGICAL SAMPLES FOR LAB ASSAY DEVELOPMENT

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项工作不是标准的研究方案。这是一种IRB批准的采集人体生物样本的方法，包括血液、尿液、粪便、精液、唾液或母乳，用于开发支持预期未来临床研究或正在进行的研究所需的药物和生化标志物测定，并评估资助申请的可行性。具体目标：为了收集必要的样本，我们需要开发各种实验室检测。 背景和意义：许多检测方法的开发都需要生物样品，以验证特定生物样品中的检测方法。这些试验将帮助我们证明试验的可行性和试验的性能特征，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.