Bioequivalence and Bioavailability Forum

Dear Sir,

I have some queries regarding conduction of BE study of Tacrolimus.

We are planing to do cross-over BE pilot study.

I have refered some previous studies, in which washout period is kept 14 days for some and 21 days for some studies.

we are planing to keep 14 days washout period and sampling upto 120.00 hrs. i thing we have to increase sampling hrs. and 14 days wash-out period is okay? if yes, plz justify.

Here, in this case we have to do "whole blood analysis". So i want to ask that, which cretical points should be cosidered while doing "W.B.A." and how mush amount of blood is sufficient to carry out "W.B.A."

Please guide me regarding above issues.