Bioequivalence and Bioavailability Forum

Dear all,

We are planning to conduct a BE study of Venlafaxine XR capsules for Brazil submission. US-FDA recommends to conduct Bioequivalence study of Venlafaxine XR capsules only in fed conditions because of safety issues in fasting state. I would like to know about the safety concerns when dosed in fasting conditions. Is it reliable to carry out BE study for the said drug in fasting conditions? Can anyone provide me any data on safety issues for justifying the non conductance of BE study in fasting state.

Thanking You in anticipation.

Regards,
Madhav Rao