Bioequivalence and Bioavailability Forum

Hi sury,

❝ Can we use the pharmacokinetic parameter ISCV for the sample size estimation for the clinical endpoint bioequivalence study?

That is a catastrophic approach. It will most likely lead to way too low power because PD endpoints are often (I am not saying always) somewhat more variable both between and within subjects.

❝ is it will be in accordance with the regulatory requirement?

There is no specific requirement telling you what to do. But if you do something along the lines of thinking PK and PD have the same variability, an asssumption which to the best of my knowledge does not have any theoretical or practical backing, then you may be headed directly for a futile trial; you will be exposing volunteers to IMP without any truly justified anticipated benefit and that would be a strong ethical concern.

The fact that it is also a royal waste of money is of course only secondary.