Bioequivalence and Bioavailability Forum

Dear Dr_Dan and Auditor,

I agree with Dr_Dan.

❝ 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

One of our study, we've the same situation that auditor have. We've decided to give both study results (with and without outlier). But, we've a note to file from investigator in the subject's CRF that there has been a suspicion about vomitting.

I might be wrong but in my opinion giving both results (with and without outlier) are the best choice if you have other evidence other than statistics.

Kind Regards,

Erkin