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

CPT Pharmacometrics Syst Pharmacol. 2015 Oct;4(10):565-75. doi: 10.1002/psp4.12015. Epub 2015 Sep 22.

Abstract

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.