ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies

Author:

Shah Rashmi R.1,Morganroth Joel2

Affiliation:

1. Rashmi Shah Consultancy Ltd; Gerrards Cross; UK

2. eResearch Technology; Philadelphia; PA; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference23 articles.

1. Committee for Medicinal Products for Human Use ICH note for guidance on the nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals (ICH S7B) (CHMP/ICH/423/02) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002841.pdf

2. Committee for Medicinal Products for Human Use ICH note for guidance on the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (ICH E14) (CHMP/ICH/2/04) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002879.pdf

3. Committee for Medicinal Products for Human Use ICH topic E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs questions and answers (EMEA/CHMP/ICH/310133/2008) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002878.pdf

4. Committee for Medicinal Products for Human Use ICH topic E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs questions and answers (EMA/CHMP/ICH/310133/2008) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002878.pdf

5. Electrocardiographic QTc changes due to moxifloxacin infusion;Malik;J Clin Pharmacol,2009

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