Bioequivalence and Bioavailability Forum

Dear All,

I would like to ask you about the safety concerns during the Moxifloxacin study.
As you can see, the chapter Warnings of Prescribing information for Avelox states that "Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. The drug should be avoided in patients with known prolongation of the QT interval..."
So one can conclude that it will be important to add the exclusion criteria about size of QT. Good.
The question is: what about the follow-up control of ECG for safety reasons? (just before dosing - to exclude in case of QT prolongation and after dosing - to monitoring possible significant prolongation)