Bioequivalence and Bioavailability Forum

Dear Auditor
According to CPMP/QWP/EWP/1401/98 Rev. 1 unbiased assessment of results from randomised studies requires that all subjects are observed and treated according to the same rules. These rules should be independent from treatment or outcome. In consequence, the decision to exclude a subject from the statistical analysis must be specified in the protocol and made before bioanalysis. Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics. Bad luck
However, you can try to present both study results (with and without outlier) to the authorities but in this case you need a reasonable explanation why the subject under discussion is an oulier (cave: Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons!). You need to find evidence in the subject´s medical history, behaviour, state of health etc. which allows to assume that this subject behaves different.
If the subject shows a different profile for the reference product you might have a chance. If you want to exclude the subject due to a different profile under test, no way!
Hope this helps
Kind regards
Dan