Renal studies are a critical part of an IND submission (medications and renal clearance) with our aging population and increase in the chronic kidney disease (CKD) population. Study design and implementation is critical to quality data and timelines being met by the site. This forum will include presenters from the FDA, industry and a clinical trial site who have knowledge, experience, and publications that support their position in the industry and current information as it relates to the FDA guidelines, industry needs, and clinical trial site conduct.

Learning Objectives:
Define FDA guidelines for renal studies
Discuss the design of renal studies in meeting the FDA requirements
Discuss analysis for reduced renal impairment study.