Bioequivalence and Bioavailability Forum

Dear Helmut,

I'd like to explain about the situation. The problem was in the reference data of the reference product showed Tmax was around 1-2 hours. So the person (with less experience in this product) who developed the protocols suggested to design the blood withdrawal timepoint to be (0 hr) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,.. and so on. The protocol were developed in this manner for 2 sponsors together and both of them considered and came back with approval signature.

After we conducted the first study and finished the plasma analysis, we found that the first timepoint after dosing the concentration were at the Cmax from almost all of the subject. Then we knew even the result is BE or not BE, we could not rely on it and the regulatory body will not accepted this result.

This brought to my question for experienced person (include you, of course !!!) to teach me some suggestion for this scenario because we'd finished the dosing part of the second study and ready for plasma analysis. We think if we work on plasma analysis, the final result may come to the same situation with the first study. So we'd like to suggest sponsor to terminate the study and redesign the protocol to suit the PK characteristics found.

Thank you for all comment

YT