Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Outliers• Solution II• Stay with the parametric method, but• evaluation of both the full (original) data set, and thereduced data set (outliers exluded), and• discuss influence on the outcome of the study.• In accordance with EMEA’s Q&A #3:• Exceptional reasons may justify post-hoc data exclusionbut this should be considered with utmost care. In such acase, the applicant must demonstrate that the conditionstated to cause the deviation is present in the outlier(s)only and absence of this condition has been investigatedusing the same criteria for all other subjects.• Results of statistical analyses with and without the groupof excluded subjects should be provided.Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 20