Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Sample Size: Sensitivity Analysis• Observations• Subsets of size 12 lead to more consistent results.• If you have stated such a procedure in your protocol, even BEmay be claimed in both subsets, and no further study will benecessary.• If you want to use the upper CL in sample size estimation, youalso get more consistant values.• If you have some previous hints of high intra-subject variability(>30%), a pilot study size of at least 16 subjects is reasonable.• Conclusions• Small pilot studies (sample size