Bioequivalence and Bioavailability Forum

Hi,

Do you think that it is correct to have as assumption in a BE protocol that both conditions are satisfied (for deciding about inclusion of AUC0-t and AUC0-inf):

AUC0-t is a reliable estimate of extent of absorption if Clast is 0 or if Clast is >0 and the ratio AUC0-t/AUC0-inf equals or exceeds a factor of 0.8 (i.e. %AUCextra is less or equal 20%)

AND

AUC0-inf is considered a reliable estimate of extent of absorption if Clast is <0 or the ratio AUC0-t/AUC0-inf equals or exceeds a factor of 0.8 (i.e. %AUCextra is is less or equal 20%)

I have seen this in a document and I am a bit puzzled. I am used to see only the 1st assumption, i.e. AUC0-t is not reliable if not 80% of AUC0-inf

Thank you!