Bioequivalence and Bioavailability Forum

Dear Forum Members,

As per current EMA guideline with respect to the exclusion of the subject, It states in section Reasons for exclusion that
“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 made before bioanalysis.”

Now my question is, how much it is acceptable (complying with guideline) to continue the subject in the study having vomiting in period 1 and decision to exclude the subject taken before Bioanalysis? Further in this situation should we analyze the plasma samples of subject who will not be considered for PK and stats?

The reason to continue the subject in the study inspite of vomiting is to have data for safety evaluation and second reason is that we have experience of volunteers informing about vomiting (or even sometimes self induced vomiting) so that they can be excluded from the study (with full compensation).

Your comments will be highly appriciated.

Best Regards,

Ratnakar