Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
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Slide 14<br />
Method of Correcting <strong>QT</strong> <strong>for</strong> Heart Rate<br />
• Historical population <strong>for</strong>mula<br />
• Experimental population <strong>for</strong>mula<br />
• Individual correction <strong>for</strong>mula<br />
‣ 30+ non-treatment values over range of heart rates<br />
‣ Heart rate range should cover heart rate expected with treatment<br />
• Model based<br />
‣ RR – is a covariate in a repeated measures model<br />
Dmitrienko & Smith (2002) Drug Inf J 36:269-279<br />
Dmitrienko & Smith (2003) Pharm Stat 2:175-190
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