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  Accueil > Recommandations & documentations

  Recommandations réglementaires :
   

ICH
Health Canada Draft Guidance for Industry: Guide for the Analysis and Review of QT/QTc Interval Data

  Nos coups de coeur du trimestre :
   

Darpo B, Nebout T, Sager PT. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. J Clin Pharmacol. 2006 May; 46(5):498-507
Darpo B, Agin M, Kazierad DJ, Layton G, Muirhead G, Gray P, Jorkasky DK. Man versus machine: is there an optimal method for QT measurements in thorough QT studies? J Clin Pharmacol. 2006 Jun; 46(6):598-612.
Sadanaga T, Sadanaga F, Yao H, Fujishima M. An evaluation of ECG leads used to assess QT prolongation. Cardiology. 2006; 105(3):149-54.
Badilini F, Sarapa N. Implications of methodological differences in digital electrocardiogram interval measurement. J Electrocardiol. 2006 Oct; 39(4 Suppl): S152-6.

  Liens :
   

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Food and Drug Administration
Health Canada
Drug Information Association
Agence Française de Sécurité Sanitaire des Produits de Santé