Bioequivalence and Bioavailability Forum

Hello,

in the EMA's "Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP)" it states the lack of incurred sample reanalysis data for a bioequivalence study can be justified. One of the points that should be adreessed is

• 90% confidence interval:
  As one element of such justification, if applicable, the applicant could also take into consideration the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability.

I would like to ask if someone has ever provided these data and how the probability of a false positive outcome can be calculated. I was thinking of using simulations but it is not clear which parameters should I vary and which distributions to use (i.e. mean and sd).

Thank you in advance,

Irene