Bioequivalence and Bioavailability Forum

Dear Skar

❝ The reason for my doubt (Normally we use Expected deviation of 5% or 7.5% in sample size calculation for bioequivalence study. please suggest me the maximum Expected deviation that can be used for sample size calculation?) is:

Maximum Expected deviation can be used depending on the situation, literature, pilot study or sponsor's point of view. I have seen studies, accepted by regulatory, planned on sample size caculated with expected deviation of 10% or sometimes more. For example, if a pilot study shows a deviation of 10% and variability around 15%. Then one can plan a study with sample size based on 10% expected deviation, variability=15%, power=80% or 90% (on your choice).

But i will suggest that if expected deviation (from pilot study) is =>15% then one should definetly go for reformulation. But if one is expecting deviation to be between 10% to 15% then variability of the molecule should be low (shown in literature or pilot study).

Regards,
GSTATS
www.gstatsolutions.com