Bioequivalence and Bioavailability Forum

Hi Murthy,

❝ A full wash out was considered…

Consider avoiding such a design in the future. Start administering the respective other for­mu­la­tion immediately after the last sample harvested in the first period. That’s called a “switch-over” design and stated in EMA’s GL:

In steady-state studies, the washout period of the previous treatment can overlap with the build-up of the second treatment (direct switching), provided the build-up period is suf­fi­ci­ently long (at least 5 times the terminal half-life).

This not only “saves” one biosample per subject, it also shortens the duration of the study and there­fore reduces the chance of drop-outs.

❝ …and in protocol it was stated about Cτ,ss is the concentration at the end of dosing interval in steady state.

OK.

❝ […] the requirements as per the new or draft guidelines shall also be addressed to avoid further queries from regulatory at the time of submission.

Correct.

❝ Since there are no time point deviations in sample collection i have to check BE for concentration at 12 hr or 24 hrs on day 6.

If you have no diurnal variations / time dependent PK C₁₂ – or C₂₄ otherwise. Know the drug/for­mu­lation and avoid ambiguities in the next protocol.