TL13: Understanding the Dose-Response Relationship in Practice
*Melanie Lai-Shan Chan, Eli Lilly Inc. 

Keywords: dose-response,MCP-mod,dose selection,minimum effective dose

The dose-response relationship is important but difficult to assess in drug development. Regulatory agencies encourage sponsors to describe the full dose-response curve and estimate the minimum effective dose. MCP-Mod is a useful method in theory. However, dose finding studies are commonly designed using a small number of doses and a narrow dose-range, often focused on the upper end of the dose-response curve. This round table will discuss the progress industry has made in assessing the dose-response relationship in practice as well as ongoing challenges. The sharing of success stories is encouraged.