Abstract Biomarkers have the potential to accelerate drug development, as early indicators of improved clinical response, to improve patient safety, and for personalised medicine. However, few have been approved through the biomarker qualification pathways of the regulatory agencies. This paper outlines how biomarkers can accelerate drug development, and reviews the lessons learned by the EU […]
NAFLD and NASH biomarker qualification in the LITMUS consortium – Lessons learned.
April 1, 2023
J Hepatol