Bioequivalence and Bioavailability Forum

Dear Charl,

thanks for your reply. The complimentary study phase I started off at phase II of the original/primary study. the washout is 3 wks so the 2nd phase of the complimentary was 3 wks away from the 2nd phase of the original study.
We did the same protocol controls so the study is basically the same except for the issue of dates.

1. Proving conditions would probably require submission of source documents copies in the BE file from both studies and i cant think any other way.
   
2. We do the stability tests right from when we did first dosing so we are kind of covered on this issue.

Well, we are planning to do test for equivalence on the first part where the bulk of the sample size is and then add up the whole lot (28) and test it as a whole study and compare results hoping it pass well in both cases with good power. I hope this is an acceptable approach.

thank you again so much
kind regards