Assessing proarrhythmic potential of drugs when optimal studies are infeasible

Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the “Thoro...

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Veröffentlicht in:	The American heart journal 2009-05, Vol.157 (5), p.827-836.e1
Hauptverfasser:	Rock, Edwin P., MD, PhD, Finkle, John, MD, Fingert, Howard J., MD, Booth, Brian P., PhD, Garnett, Christine E., PharmD, Grant, Stephen, MD, Justice, Robert L., MD, Kovacs, Richard J., MD, Kowey, Peter R., MD, Rodriguez, Ignacio, MD, Sanhai, Wendy R., PhD, Strnadova, Colette, PhD, Targum, Shari L., MD, Tsong, Yi, PhD, Uhl, Kathleen, MD, Stockbridge, Norman, MD, PhD
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Biological and medical sciences Cardiac arrhythmia Cardiology. Vascular system Cardiovascular Controlled Clinical Trials as Topic - methods Critical path Disease Drug Approval - organization & administration Drug Evaluation, Preclinical - methods Drugs, Investigational - adverse effects Electrocardiography Electrocardiography - drug effects Federal regulation Heart rate Humans International Cooperation Long QT Syndrome - chemically induced Long QT Syndrome - physiopathology Medical sciences Mortality Pharmaceuticals Potassium Product safety Risk assessment Studies
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