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home > ict > winter 2019 > concentration-qt modelling in early phase clinical studies
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International Clinical Trials

Concentration-QT Modelling in Early Phase Clinical Studies

Long QT syndrome is a cardiac side effect that can occur with certain pharmaceuticals. After each beat, the heart repolarises, but, with long QT syndrome, this process does not occur correctly. This can lead to a condition known as Torsadede- point arrhythmia, which can cause irregular heartbeats, fainting, and even sudden death, particularly when the patient is under stress or during exercise.

Once it was understood that drugs can cause long QT syndrome, studying cardiac repolarisation became an important part of the drug development process. Regulators now mandate assessment of whether a new drug has a tendency to prolong the QT interval as part of the clinical development process.

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Dr Andreas Lindauer has been a Senior Consultant at SGS Exprimo since 2014. He studied pharmacy at the University of Bonn, Germany, subsequently completing a PhD in clinical pharmacy, focussing on PK/ PD modelling in oncology and the central nervous system.
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Dr Andreas Lindauer
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