Points to Consider to Design the ‘Thorough QT/QTc Study’

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  • Thorough QT/QTc試験のデザインに関する留意事項
  • Thorough QT QTc シケン ノ デザイン ニ カンスル リュウイ ジコウ

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The ‘thorough QT/QTc study’ has a critical role in evaluating QT/QTc interval prolongation of a drug. In designing the ‘thorough QT/QTc study' it is important to consider cause of variation of QT intervals and risk factors of QT prolongation, such as reliability of QT interval measurement, diurnal variation, pharmacokinetics, pharmacokinetics-pharmacodynamics relationship, age, gender, electrolyte abnormalities, concomitant drugs, concomitant diseases, etc. Choice of parallel or cross-over design and sample size determination are also discussed.

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