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在体外诊断试验开发阶段的实用指导和关键要求

Gerard J Davis1

  • 1Abbott Diagnostics Division, Abbott Laboratories, Oncology Research (D09NC), Building AP20/3, 100 Abbott Park Road, Abbott Park, Chicago, IL, 60064, USA. gerard.davis@abbott.com.

Digestive diseases and sciences
|February 28, 2025
PubMed
概括

生物标志物的开发通过不同的阶段进行,要求越来越多的测试成熟度和分析严谨性. 成功的生物标志物翻译需要强大的测试,广泛的验证和监管对准临床使用.

关键词:
生物标志物的临床翻译过程.生物标志物发展到临床试验生物标志物测试的开发和开发临床使用的生物标志物.在IVD的发展和发展方面.

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