Bioequivalence and Bioavailability Forum

Hi everyone,

1) For BA/BE studies, FDA suggested 3 or timepoints are need to characterize the terminal phase of a plasma concentration-time profile. I know Canadian guidance requires a parameter called AUC0-t/AUC0-inf ratio to be at least 80%(or 90%). Does FDA follow something similar as well?


2) What is the minimum number of reportable concentrations (above BLQ) a subject should have in order to be included in the BA/BE statistical analysis?

Thanks

John