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Dear All,
Please share your experience re the following bioequivalence issue:
Results of a recent bioequivalence study indicate 90% CI for AUC0-t and
AUC0inf well within the required acceptance range
of 0.8 to 1.25. However, the statistical power calculated for AUC0-t
was below 80% and according to a sample size estimate
an additional 12 subjects need to beenrolled to to achieve 80% power.
Do Regulatory authorities judge bioequivalence
on the CI within the stated acceptance range as well as on a minimum of
80% power?
Thank you
Hannes Breedt
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