Bioequivalence and Bioavailability Forum

Dear Ghousia Saba,

❝ If we conduct the bioequivalence with clinical end points and there are deviations in the conduct of the study e.g. included patients do not meet the entry criteria or change in dose timing.

Subjects not meeting the inclusion criteria is a major protocol deviation. The subjects who did not meet the inclusion criteria should not be enrolled in the study. It may raise regulatory concern.
The change in dose timings may be acceptable if the same dose timings are adopted in both the periods if it is two way, cross over study.

❝ however, the results show that these deviations have not effected the outcomes and there is treatment success. however, these may result in AE.

The incidence of Adverse Events due to enrollment of subjects who did not meet the inclusion criteria may raise a regulatory concern.

❝ Should we include such subjects in final data analysis for BE or these should be excluded?

It is better to provide two sets of analysis, including and excluding those subjects.

Priya.