Analytical Services Center for Medications Development Program

药物开发计划分析服务中心

• 批准号: 8890008
• 负责人: YONG HUANG
• 金额: $ 53.26万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2018-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8890008
• 关键词: Archives; Biological; Biological Assay; Biological Markers; Chemistry; Clinical; Clinical Trials; Cocaine; Collection; Contractor; Contracts; Data; Databases; Development; Devices; Drug Addiction; Drug Kinetics; Drug user; Electronics; Hair; Illicit Drugs; Label; Laboratories; Methamphetamine; Molecular; Naltrexone; National Institute of Drug Abuse; Outcome Measure; Peptides; Pharmaceutical Preparations; Plasma; Program Development; Proteins; Records; Reporting; Resources; Saliva; Sampling; Secure; Services; Site; Substance Abuse Detection; Urine; analytical method; clinical research site; data management; drug of abuse; drug testing; pre-clinical; research and development; sample collection; screening; small molecule; therapy development; treatment program

The objective of Task A is to develop and validate analytical methods to quantify new medications, metabolites, illicit drugs and endogenous biomarkers in plasma, urine and other biological matrices. The validated assays will be used for preclinical and clinical pharmacokinetic (PK) studies in order to support NIDA's medications development programs. The objective of Task B is to quantify a variety of compounds including new medications, their metabolites, illicit drugs and endogenous substances or biomarkers in plasma/serum, urine and other biological matrices, such as saliva or hair. The compounds to be quantified include, but are not limited to, the following drugs and their metabolites: cocaine, methamphetamine, naltrexone, and other potential medications under development, such as GSK 598809. Task C: One important aspect of medication development for treatment of abused drug addiction involves identifying the drug user by screening urine samples and the assessment of the medication in reducing the use of the target abused drug by participating subjects. This clinical outcome measure requires assay of urine samples for the abused drugs and their metabolites. This task can be divided into two parts: a) urine abused drug screening; and b) urine abused drug confirmatory/quantitative analysis. Task D: On-site drug testing devices can quickly identify the drug user and the common abused drugs. To support the clinical trial for abused drug treatment program, the Contractor will purchase and distribute 4-9 multi-panel urine on-site drug testing devices to each clinical site. Task E: Clinical trials for drug addiction treatment require collection of biological samples for analysis. To provide such services, the Contractor will purchase and supply all necessary sample collection and shipment containers, sample labels and shipment cartons, etc. to each clinical site. Task F: The Contractor shall prepare and maintain all assay results in electronic files for submission to NIDA with corresponding reports and for submission to the data management centers designated by NIDA. The objective of Task G is to archive and maintain all records, which includes laboratory notebooks, hard copies of raw data, and databases of assay results on disk in secure storage for a period up to 5 years in case a GLP audit is required by FDA in connection with an IND or NDA submission.

任务 A 的目标是开发和验证分析方法，以量化血浆、尿液和其他生物基质中的新药物、代谢物、非法药物和内源性生物标志物。经过验证的检测方法将用于临床前和临床药代动力学 (PK) 研究，以支持 NIDA 的药物开发计划。 任务 B 的目标是量化各种化合物，包括新药物、其代谢物、非法药物和血浆/血清、尿液和其他生物基质（例如唾液或头发）中的内源性物质或生物标志物。待量化的化合物包括但不限于以下药物及其代谢物：可卡因、甲基苯丙胺、纳曲酮以及其他正在开发的潜在药物，例如 GSK 598809。 任务 C：用于治疗滥用药物成瘾的药物开发的一个重要方面包括通过筛查尿液样本来识别吸毒者，并评估药物以减少参与受试者对目标滥用药物的使用。这种临床结果测量需要对尿液样本进行滥用药物及其代谢物的检测。这项任务可分为两部分：a）尿液滥用药物筛查； b) 尿液滥用药物确认/定量分析。 任务D：现场毒品检测设备可以快速识别吸毒者和常见滥用药物。为了支持滥用药物治疗计划的临床试验，承包商将购买并向每个临床地点分发 4-9 个多组尿液现场药物检测设备。 任务E：毒瘾治疗的临床试验需要收集生物样本进行分析。为了提供此类服务，承包商将购买并向每个临床地点提供所有必要的样品采集和运输容器、样品标签和运输纸箱等。 任务 F：承包商应准备所有化验结果并将其保存在电子文件中，以便连同相应的报告一起提交给 NIDA 以及提交给 NIDA 指定的数据管理中心。 任务 G 的目标是归档和维护所有记录，其中包括实验室笔记本、原始数据的硬拷贝以及磁盘上的化验结果数据库，安全存储期限长达 5 年，以防 FDA 要求进行 GLP 审核与 IND 或 NDA 提交有关。