Bioequivalence and Bioavailability Forum

Dear HS,

in practice this will make a difference to very few studies. Never say never, of course, but the difference in acceptance range that the different options allow for the constant will only seldomly change the regulatory decision.

But if you insist, then I will take this view on it:
The guideline says:
"(...) For these parameters the 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%."
Look closer. Did you see it? If EMA's wish is to work with two decimals on the acceptance range then so be it. Then they could have chosen to write that constant with two decimals. However, working with "X decimals" is in itself dubious to some. In a mathematical sense when uncertainty is involved it might make a bit more sense to work with X significant digits. The EMA could have said they want the CI's with X signif. digits on both ends and hence also specified the constant with X significant digits. This would at least follow some stringency.
Coincidentially the last digit in the constant is 0 so specifying with two or three decimals (or sigdigs) does not make much of a difference anyway.