This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identify which assay parameters and key statistical measures need to be considered when developing a biomarker assay. A diverse group of more than 40 scientists participated in the workshop. The workshop and subsequent working dinner stimulated robust discussion. While a consensus on best practices was not achieved, some common themes and major points to consider for biomarker assay development have been identified and agreed on. The focus of this conference report is to summarize the presentations and discussions which occurred at the workshop. Biomarker assay validation is a complex and an evolving area with discussions ongoing.

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生物标志物方法开发和适用性验证的最佳实践：会议报告

这份会议报告总结了在德克萨斯州圣安东尼奥举行的美国药物科学家协会 (AAPS) PharmSci360 大会之前举行的全天研讨会“生物标志物方法的开发和适用性验证的最佳实践”， 2019 年 11 月。研讨会的目的是汇集生物标志物检测开发的思想领袖，以确定在开发生物标志物检测时需要考虑哪些检测参数和关键统计措施。由 40 多名科学家组成的多元化小组参加了研讨会。研讨会和随后的工作晚宴引发了热烈的讨论。虽然没有就最佳实践达成共识，但已经确定并商定了一些共同主题和生物标志物检测开发需要考虑的要点。本次会议报告的重点是总结研讨会上的演讲和讨论。生物标志物测定验证是一个复杂且不断发展的领域，讨论仍在进行中。