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The following message was posted to: PharmPK
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
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
Shoaf for their kind replies on my question with regard to the
bioequivalence of inhaled products.
Department of Pharmacy
University of Patras
Rio 26500, Patras
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