Bioequivalence and Bioavailability Forum

Respected Members,

I want your valuable comments and experience in below matter.

I want to go for Drug X for EU submission. It has less %CV.

Conventionally we go for Pilot and then by estimating %CV, Pivotal is sought for. Here, can we not go for 2 stage approach proposed by POTWIN etal from first shot itself as we are likely to meet the criteria(considering the formulation is best prepared)at low sample size. If not then there is always the second stage to make up the power. Why to unnecessarily first go for pilot batch.....do the pilot Bio study in say 14 subjects.....It passes.....Go for Exhibit batch.....Do Pivotal in say 24 subjects and obtain the results. Instead of this directly cant we go for Exhibit batch and Two stage approach....

By this we can preserve our Resources.

Do any one has experience of handling regulators in this matter...