Bioequivalence and Bioavailability Forum

I heard the same question during the BE-GBH meeting in Bethesda (and had a coffee Helmut). The short and sweet answer was you can submit your analysis whatever the software you are comfortable FDA runs their own analysis using internal tools, in the event the results differs by what magnitude is subjective) it triggers a review question.

Having said that I agree with the original post we need to do some kind of qualification, simple example is to do a cross comparison between R analysis and SAS/WinNonlin analysis (even better a 3 way comparison) This strategy worked in the past. It is better to have some validation than having no validation.

Regards,

Achievwin