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ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs

  • QT / QTc Interval Prolongation
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Authors and Affiliations

  1. Cardiovascular Research, AstraZeneca LP, 1800 Concord Pike, C3B-526, Wilmington, DE, USA

    Philip T. Sager MD, FACC, FAHA (Clinical Professor of Medicine)

  2. University of Medicine and Dentish, New Jersey, USA

    Philip T. Sager MD, FACC, FAHA (Clinical Professor of Medicine)

  3. Medical Sciences, Institut de Recherches Internationales SERVIER, Paris, France

    Thierry Nebout MD

  4. Daiichi Medical Research, Montvale, New Jersey, USA

    Borje Darpo MD, PhD, FACC

  5. Department of Cardiology, Karolinska Hospital, Stockholm, Sweden

    Borje Darpo MD, PhD, FACC

Authors
  1. Philip T. Sager MD, FACC, FAHA
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  2. Thierry Nebout MD
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  3. Borje Darpo MD, PhD, FACC
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Corresponding author

Correspondence to Philip T. Sager MD, FACC, FAHA.

Additional information

The aim of this article is to give a summary of the International Conference on Harmonisation (ICH) E14 document as it stands after having reached step 4 in Brussels, Belgium, May 2005. The authors are representatives for the pharmaceutical industry in the United States (Pharmaceutical Research and Manufacturers of America [PhRMA]; PTS) and Europe (European Federation of Pharmaceutical Industries and Associations [EFPIA]; BD and TN) on the Expert Working Group for this document. Interpretations of some recommendations given in E14 may differ in regions (European Union, United States, Japan), and the opinions expressed in this article are those of the authors and do not necessarily reflect the views of the ICH Expert Working Group, PhRMA, or EFPIA or individual pharmaceutical companies.

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Sager, P.T., Nebout, T. & Darpo, B. ICH E14: A New Regulatory Guidance on the Clinical Evaluation of QT/QTc Internal Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Ther Innov Regul Sci 39, 387–394 (2005). https://doi.org/10.1177/009286150503900407

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  • DOI: https://doi.org/10.1177/009286150503900407

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