临床药理质量保证计划全球艾滋病毒和共感染药物开发
Robin DiFrancesco1, Troy D Wood1, Raymond Cha1
1Center for Integrated Global Biomedical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, New York, USA.
Clinical pharmacology and therapeutics
|March 2, 2026
概括
临床药理学质量保证计划通过严格的质量控制和培训,提高药物试验的完整性. 该计划确保可靠的数据用于开发有效的传染病治疗方法.
科学领域:
- 临床药理学 临床药理学
- 传染病研究 传染病研究
- 生物医学科学 生物医学科学
背景情况:
- 20世纪80年代获得性免疫缺陷综合征 (艾滋病) 的出现,迫使国家卫生研究院 (NIH) 建立研究网络,以开发抗逆转录病毒疗法.
- 这些网络整合了学术药理学实验室来测量药物度,从而实现了药理动力学和药理动力学分析.
- 质量保证举措对于保持临床场所和实验室数据完整性至关重要.
研究的目的:
- 总结过去十年临床药理学质量保证 (CPQA) 计划的发展和影响.
- 突出CPQA计划在支持传染病临床试验方面的作用.
- 详细说明实施的质量保证机制,以确保可靠的研究数据.
主要方法:
- 成立于2008年的CPQA计划为临床药理学研究提供培训和质量保证.
- 关键组成部分包括生物分析同行评审计划,ISO-17043认证的外部能力测试计划和实验室评估计划.
- 提供关于研究协议,生物分析方法验证以及遵守国际实验室和监管标准的培训.
主要成果:
- 自2015年以来,已经向研究人员和实验室颁发了超过4,500份教学证书.
- 一个生物分析学同行评审计划已经批准了超过350个测试,用于21个人类生物矩阵中的100多个分析物.
- 一个外部能力测试程序已经完成了15个分析的35轮测试,证明了一致的质量.
结论:
- 该CPQA计划已大大有助于确保临床药理学研究数据的质量和可靠性.
- 已建立的基础设施有助于快速应对新出现的共感染病原体,如SARS-CoV-2.
- 该计划对质量保证的全面方法加强了对传染病有效治疗方法的开发.
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