Bioequivalence and Bioavailability Forum

Dear all,

As per the EMA guideline for the BE of MR products,

A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected.

Now Product x is recommended to be taken under fasting condition.

For SD study under fasting condition no accumulation is observed.
For SD study under fed condition accumulation is observed.

Similarly Product is to be taken with food only and after SD study accumulation is seen for fasting but not for fed study.

Do steady state study need to be performed? (steady state study to be performed on SPC recommended state-fasting/fed)

Regards,
PJS