Nonclinical Kidney: Phase I

FEASIBILITY1 SCOPING2 RESEARCH3 SUBMITTED4 QUALIFIED5

blue U.S. Food & Drug Administration (FDA)

green European Medicines Agency (EMA)

orange Pharmaceutical & Medical Devices Agency Japan (PMDA)

Overview

Following review of the first ever biomarker qualification data submission by PSTC, the FDA (2008), EMA (2007), and PMDA (2010) issued a formal regulatory opinion that urinary beta2-microblobulin, urinary total protein, urinary albumin, urinary KIM-1, urinary clusterin, urinary cystatin c, and urinary trefoil factor 3 (TFF-3) can be utilized on a voluntary basis, in addition to serum creatinine and blood urea nitrogen, in GLP rat toxicology studies to monitor drug-induced kidney injury.