Bioequivalence and Bioavailability Forum

Dear drplacebo!

Although the new European BE-Guideline was announced as a kind of
  Cookbook
let's see was has changed:

EMEA (2001):
The number of subjects required is determined by

1. the error variance associated with the primary characteristic to be studied as estimated from a pilot experiment, previous studies, or from published data,
   
2. the significance level desired,
   
3. the expected deviation (delta) from the reference product compatible with BE and,
   
4. the required power.

So if you expect +12% from your pilot study, and variability + budget allows, why not?

EMEA (2008 draft):
The number of subjects to be included in the study should be based on an appropriate (sic!) sample size calculation.

I see!