Bioequivalence and Bioavailability Forum

Dear Members,

As per text stated in "Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies" for Health Canada," If a subject withdraws from the study for personal reasons or because of non-compliance with the protocol (e.g., positive drug test) before completing at least two periods of the study, the subject’s blood samples do not have to be analysed."

What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.

Can regulatory agency raise a query???? or any plausible significances occurs which leads to impact the study results.

Kindly, share your opinions.


Thanks in advance.

Shreyas Goswami.