Bioequivalence and Bioavailability Forum

Hi Helmut,

Thanks for your thorough information about analyzing all dosed subjects.
I read the mentioned guideline "BE-GL, section Subject accountability" and I have a question about replacing people in the study. Regarding the following sentence from the guideline:

"It is not acceptable to have a protocol which specifies that ‘spare’ subjects will be included in the analysis only if needed as replacements for other subjects who have been excluded."

Is it also not acceptable to replace subjects even if the number of excluded subjects is more than the number of considered dropouts?
For example, if 7 subjects are withdrawn during the study after receiving the dose, and the number of considered dropouts are 5 subjects, is there any way we can replace 2 subjects that were withdrawn over the number of dropouts?

Thanks in advance

---

Edit: Relax; see also this post #9. Another post with identical text deleted. [Helmut]