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Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification
Author(s) -
Chen Ru,
Sanyal Sarmistha,
Thompson Aliza,
Ix Joachim H.,
Haskins Kylie,
Muldowney Laurie,
Amur Shashi
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1093
Subject(s) - food and drug administration , medicine , drug , drug development , nephrotoxicity , approved drug , biomarker , clinical research , drug approval , pharmacology , medical physics , intensive care medicine , kidney , chemistry , biochemistry
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.