Thorough QT Study: Design Features for Consideration - IIR

Slide 17
Can Adequate Exposure to Test Drug be Achieved with a Single
Dose or Does Test Drug Require Multiple Administrations to
Achieve Steady State
• The single dose scenario applies when drug is to be used as
single-dose PRN or is so well tolerated that a large multiple at
intended maximum therapeutic dose can be administered with
impunity
• Impacts the recommended possible primary comparisons