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Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group

As of January 2023, the E14/S7B Implementation Working Group (IWG) has transitioned into a Discussion Group (DG) to evaluate implementation of first stage Q&As and outline development of second stage Q&As. At the conclusion of a one-year term, the DG has recommended next steps including returning to an IWG to develop second stage Q&As.

The E14/S7B DG:

  • Exchanged information and shared experiences about implementing stage 1 Q&A.
  • Discussed results from ongoing studies that investigate into the proarrhythmia potential of substances that might not need detailed QT focused clinical evaluation, such as drugs of low systemic exposure, oligos, peptides, etc.
  • Discussed results from ongoing studies that investigate into the proarrhythmia potential of drugs with certain potential of QT prolongation.
  • Provided recommendations on next steps.

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