PharmPK Discussion - Power of bioequivalence studies

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On 5 Jan 2003 at 18:01:30, (avgoust.at.upatras.gr) sent the message


The following message was posted to: PharmPK

Dear Colleagues,
I wish you all a happy and prosperous new year.
Could you please let me know if  the 80% requirement for the power of
bioequivalence studies (based on a cross-over design)is official in
Europe
and USA? Does this power requirement refers to the probability of
detecting a 20% difference between the two products (which is beneficial
for the consumer) or to the probability of correctly concluding
bioequivalence (correctly rejecting Ho:bioinequivalence)(which is
beneficial to the producer)? Thank you for your help.

I take this opportunity to thank D. Turck, F. Bales, P. Bhadauria, and
S.
Shoaf for their kind replies on my question with regard to the
bioequivalence of inhaled products.

K Avgoustakis
Department of Pharmacy
University of Patras
Rio 26500, Patras
Greece

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