Analytical Services Center for Medications Development Program

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、代谢物、非法药物和内源性生物标记物。经过验证的分析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、其代谢物、非法药物和血浆/血清、尿液和其他生物基质(如唾液或头发)中的内源性物质或生物标志物。需要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、纳曲酮和其他正在开发的潜在药物，如葛兰素史克598809。 任务C：药物开发用于治疗滥用药物成瘾的一个重要方面涉及通过筛选尿样和评估药物在减少参与受试者使用目标滥用药物方面的作用来确定吸毒者。这一临床结果衡量标准需要对滥用药物及其代谢物的尿样进行分析。这项工作可分为两部分：a)尿滥用药物筛查；b)尿滥用药物确证/定量分析。 任务D：现场验毒设备可以快速识别吸毒者和常见滥用药物。为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站点分发4-9个多面板尿液现场药物检测仪器。 任务E：药物成瘾治疗的临床试验需要收集生物样本进行分析。为提供该等服务，承办商将向每个临床地点购买及供应所有必需的样本收集及运送容器、样本标签及运送纸箱等。 任务F：承包商应准备和维护所有化验结果的电子文件，以便提交给NIDA和相应的报告，并提交给NIDA指定的数据管理中心。 任务G的目标是存档和维护所有记录，包括实验室笔记本、原始数据的硬拷贝和磁盘上的分析结果数据库，安全存储最长5年，以防FDA要求与IND或NDA提交相关的GLP审核。

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.