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 18<br />
What Value is Compared Between Treatments<br />
• With single dose design, 3 possibilities<br />
• With multi-administration design, 2 possibilities may be more<br />
reasonable<br />
• Change from “baseline” (as opposed to absolute value on<br />
treatment) may not be necessary<br />
‣ “Single-delta” comparison may be adequate
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