Bioequivalence and Bioavailability Forum

Dear All,

As per FDA guidelines "We recommend that if the predose value is greater than 5 percent of Cmax, you drop the subject from all BE study evaluations".

Is it applicable for fully replicated designs also, if i got greater than 5% Cmax in period 4 whether i need to exclude the subject from entire study or can we use available data for Swr calculations if subject completed two reference treatment periods.

Thanks&Regards,
Rajasekhar