Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

This tutorial aims at promoting good practices for exposure–response (E‐R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E‐R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and projects and tailored to typical clinical drug development decisions. This includes general considerations for planning, conducting, and visualizing E‐R analyses, and how these are linked to key questions.