Trial Design

Biomarkers for Drug-Induced Kidney Injury Receive Boost From EMA, FDA

The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More

FDA: How to Use Galactomannan As Aspergillosis Biomarker

Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More