评估 KIM-1 在 FDA 认证后的药物研发和研究中的应用。
Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification.
机构信息
Immediate Office, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
Clin Pharmacol Ther. 2018 Dec;104(6):1175-1181. doi: 10.1002/cpt.1093. Epub 2018 May 15.
The Biomarker Qualification Program was established at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) to expedite the integration of promising biomarkers across multiple drug development programs. The first set of biomarkers qualified in 2008 consisted of seven nonclinical safety biomarkers for the detection of acute drug-induced nephrotoxicity in rats, and included urinary kidney injury molecule-1 (KIM-1). This article discusses the use of KIM-1 in drug development and research before and after CDER's qualification of KIM-1. Use was determined by analyzing relevant documents identified by keyword searches using three databases: 1) an FDA internal database, Document Archiving, Reporting, and Regulatory Tracking System (DARRTS); 2) ClinicalTrials.gov; and 3) PubMed. The results indicate increased use of KIM-1 as a biomarker for detection of kidney injury in drug development programs reviewed by CDER, as well as in research following qualification.
生物标志物资格认证计划在食品和药物管理局（FDA）的药物评估和研究中心（CDER）设立，以加快有前途的生物标志物在多个药物开发项目中的整合。第一批在 2008 年获得认证的生物标志物包括七个用于检测大鼠急性药物诱导肾毒性的非临床安全生物标志物，其中包括尿肾损伤分子-1（KIM-1）。本文讨论了在 CDER 认证 KIM-1 前后，KIM-1 在药物开发和研究中的使用。通过使用三个数据库（1）FDA 内部数据库，文档归档、报告和监管跟踪系统（DARRTS）；2）ClinicalTrials.gov；和 3）PubMed 对使用关键字搜索识别的相关文件进行分析来确定使用情况。结果表明，在 CDER 审查的药物开发计划中，以及在认证后，KIM-1 作为检测肾脏损伤的生物标志物的使用有所增加。
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