Fixed dose/ fixed ratio combinations: are current EU and US regulatory guidelines adequate?

Time

Tue, Mar 05 8:30AM
5

Title

Fixed dose/ fixed ratio combinations: are current EU and US regulatory guidelines adequate?

Abstract Summary

Current FDC guidelines were compared to identify inadequacies in the information provided. Interviews were undertaken of those in industry to clarify if the gaps identified had affected development strategy. Approaches to fill the gaps will be presented to regulators to gain their perspective.

Poster Presenter

Yvonne Gautam
University of Copenhagen
Denmark

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