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CLINICAL PHARMACOLOGY QUALITY ASSURANCE

CLINICAL PHARMACOLOGY QUALITY ASSURANCE
临床药理学质量保证
批准号:
10168379
负责人:
EUGENE MORSE
金额:
$166.88万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-05-30 至 2021-05-29

项目摘要

项目成果

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中文摘要
翻译
NIAID临床药理学质量保证(CPQA)计划的目的是为临床药理学实验室检测来自NIAID支持的临床研究中入组受试者的样本提供全面的质量评估计划。 CPQA计划通过为实验室提供药理学能力测试和含量控制材料,并监测每个实验室的能力和含量数据,确保药理学研究数据的有效性和实验室间和实验室内的可比性。 该计划还实施新药理学测定的性能标准,开发和测试与测定相关的方法,并获取,测试,储存和分配质量控制材料和试剂。 因此,CPQA计划对于正在进行的和未来的关于评估抗HIV治疗和预防措施的研究的科学完整性至关重要。
英文摘要
The purpose of the NIAID Clinical Pharmacology Quality Assurance (CPQA) program is to provide a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies. The CPQA program ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. The program also implements standards of performance for new pharmacology assays, develops and tests methods relating to the assays, and acquires, tests, stores and dispenses quality control materials and reagents. Thus, the CPQA program is critical to the scientific integrity of on-going and future studies concerning assessment of anti-HIV treatments and preventive measures.
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Clinical Pharmacology Quality Assurance
CLINICAL PHARMACOLOGY QUALITY ASSURANCE
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