Bioequivalence and Bioavailability Forum

Dear Mr Rana,

❝ Whether US regulatory is accepting this fact? and does it show any impact in Pharmacokinetic & statistical analysis?

FDA may raises a question about the measurement of true Cmax because of insufficient early sampling times. FDA Guidance states that collection of an early time point between 5 and 15 minutes after dosing followed by additional sample collections (e.g., two to five) in the first hour after dosing may be sufficient to assess early peak concentrations. If this sampling approach is followed, FDA recommends that data sets be considered adequate, even when the highest observed concentration occurs at the first time point.
In your case, since the above sampling approach is not followed, FDA may raise on observation.