The role of the thorough QT study in drug development: A review of centrally approved drugs in Europe (2009-2012)

Time

Tue, Mar 05 8:30AM
5

Title

The role of the thorough QT study in drug development: A review of centrally approved drugs in Europe (2009-2012)

Abstract Summary

We reviewed the evaluation of proarrhythmic potential of new products centrally approved in Europe (2009 to 2012), based on information from EMA website and company dossiers. Associations between performance of and outcome of preclinical, TQT and phase 3 study data on QT prolongation were tested.

Poster Presenter

Frank Holtkamp
PhD,
Clinical Expert,
Dutch Medicine Evaluation Board (MEB)
Netherlands

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