Draft qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty

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Download document Draft qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty
Reference number EMA/CHMP/SAWP/592378/2013
Status draft: consultation closed
First published 15/10/2013
Last updated 15/10/2013

Summary

Estimating dose-response and selection of a dose for confirmatory Phase III trials and potential market authorisation is among the most difficult elements of the whole development process. 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 relationship.