Women's Health Weekly
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Cardiology
Cost of thorough QT/QTc study may be reduced to 25-30% of the cost of simple ECG
March 10th, 2005
Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation According to a study from England, "Regulatory authorities require new drugs to be investigated using a so-called 'thorough QT/QTc study' to identify compounds with a potential of influencing cardiac repolarization in man. Presently drafted regulatory consensus requires these studies to be powered for the statistical detection of QTc interval changes as small as 5 ms. Since this translates into a noticeable drug development burden, strategies need to be identified allowing the size and thus the cost of thorough QT/QTc studies to be...
Source: Women's Health Weekly (2005-03-10)
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