Bioequivalence and Bioavailability Forum

Thank you Helmut: yes; I do regard the fasted leg as the reference. The treatment lost was not the reference....it was one of the tests (fed)that did not show up for Period 3. The protocol was written and provided an overview of the data analysis done in Phoenix. It did not discuss dropout subjects and what to do if subjects dropped out. Perhaps it is a good thing if the protocol is vague on this issue............suitably vague? do you agree? Often I think it is mistake to give too much detail in a protocol, since you can create protocol violations. The FDA did not comment on this issue during their protocol review, but commented on other issues.

I will try the options you suggest: At an earlier date for a fed, fasted, sprinkled study I have run a 6 sequence type data analysis (just like this one)

All of the subjects completed the study. I showed that the result were identical in SAS (GLM) and WinNonlin and Kinetica.

Angus