Bioequivalence and Bioavailability Forum

❝ If a single dose BE study of a SR product Vs SR product...we find AUC0-last failing but AUC 0-T(Tau)(say 0-24 hrs) passing and C max and AUC0-inf is also passing.(fast and fed)and no need for steady state.

Dear Hiren, here you are forgetting one important point that calculation of AUC tau has to be done only AFTER THE DRUG REACHES STEADY STATE.
If it is calculated with a single dose study, it does not solve the purpose, because the idea of taking the AUC tau after steady state is to show that the drug concentration shows consistent level in blood/plasma and fluctuating minimally between a Maximum and Minimum concentration.
Also I would like to know with regard to AUC (0-last) that you have mentioned - Is this up to last quantifiable concentration or last concentration that you have measured. I have seen many people getting confused at this point.
Also if you can give the exact details about halflife of the drug and about your last time point, we can give better suggestions