Bioequivalence and Bioavailability Forum

Thanks Helmut,

I went with T/R ratio 90%, power 90 and came up with something like 36-40 subjects. I added a few more in case of dropouts due to the washout.

About the AUC_0-72. I did some calculation & modeling based on the t_1/2, T_max and gave the CRO a time limit of 30 mins for the 72 hour return blood draw. That is subject will be dropped from the study if they miss the cutoff time collection for the 72 hours in period 1, or their data will not be included in the stat analysis if they complete both periods but missing 72 hour sample in period 2. If the CRO can't do that then my threshold is 1 hour. One hour is acceptable since I did a comparison between AUC_0-72 and AUC_0-73 based on t_1/2 of 25-40 hours and the difference is less than 1%. Their limit of 4 hour is way too long. Otherwise I will ask to have them subjects housed for 72 hours. I don't want to mess around with a BE assessment.

John

PS. It's Friday here! Do you have the drinking smiley?