Bioequivalence and Bioavailability Forum

Dear Npavan,

pl. specify the regulatory of the study.

As in my view, we shall follow below steps:

1) calculate AUC %extrapolation for the specific subject (who has missing sample at ambulatory time point) for reference product to check absorbtion process is complete or not.

2) if AUC %extrapolation is <20%, it assures that absorbtion process is complete. Thus, we can consider that subject for PK and statistical analysis and compare profile of test and referece product.

3) if AUC %extrapolation is >20%, it says absorbtion process is incomplete. Therefore, subject required to exclude from the PK and statistical analysis of the study since reference profile is not complete.


Dear Friends,
pls correct this if anything is lacking here.


Thanks & Regards,
NIRALI