Bioequivalence and Bioavailability Forum

Dear Helmut,

❝ welcome to the club.

Thanks!

❝ Out of curiosity: What did you specify in the protocol – were there any comments by the authority and/or IEC in approval?

Nothing was stated in the protocol wrt to data analysis and there were no comments from the authority in the submission stage. However during the BE study final report review the expert was surprized by the study design:
"how come that in BE study subjects receive different amount of drug. You should re-design and re-do the study in such a way thay everybody receive the same amount of drug".
We said that it is not ethical since some subjects will get more drug than needed (risk of AEs), some subjects will get less drug (risk of tumor resistance). We also provided a link to the FDA capecitabine GL.

Experts said that ok, the design is now acceptable and commented that we have to analyze the subset of the sample with the similar amount of drug taken.

I understand that this expert's position does not have strong scientific background, however obviously I cannot tell it to the expert. That is why I need a kind of reference I could present to the expert explaining the situation.

Sincerely,

Vasily