QT Assessment in Early Clinical Development Can the Predictive Value be Enhanced to be Similar to That of a TQT study?

Posted:
15
January 2012

Following the JCP Nov 2011 publication proposing food as a viable means for demonstrating assay sensitivity for ECG assessment in clinical trials, this is now proposed alongside other potential methods at the upcoming CSRC ThinkTank meeting on QT Assessment in Early Clinical Development being held 2 Feb at the FDA Headquarters in Silver Spring.The purpose of these meetings is the formation of collaborative CSRC research groups with members from regulators, sponsors and academia with the goal to perform, promote and compile research in areas addressing identified key knowledge gaps.

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