# Bioequivalence and Bioavailability Forum 05:25 CEST

## No rounding [Regulatives / Guidelines]

Hi sudy,

» As per progesterone guidance and FDA statistical guideline, 95% uppper confidence bound should be less than or equal to zero. Now,
» 1) less than zero mean negative value, it’s very clear.
» 2) Equal to zero, i have a doubt that it is exactly zero. Because in practical situation during statistical calculation, we never get exact zero (very less chance).

Is is so difficult understanding what the “≤” symbols means?
≤ 0 reads “less than or equal to zero” (equivalently: “not greater than zero“, or “at most zero”).

» So if we have a value e.g. 0.01 or 0.001 or 0.06, If we round this value we get zero.
» Can we consider it as zero?

Nope.

» FDA given clarity for 90% confidence interval but not for 95% upper confidence bound.
» Is there any reference to report value upto 2 digits after decimal place without rounding for 95% upper bound?

No rounding according to the FDA’s guidance.
As you rightly stated, the FDA’s rounding rules are for the CI in percent. That means at the 4th (<100%) or 5th (≥100%) significant digit. IMHO, the same “logic” would mean a rounding cut-off at 0.0001 or 0.00001. If you want to go that way (which I don’t recommend) initiate a controlled correspondence with the FDA in order to avoid an RtR (see this post).

Cheers,
Helmut Schütz

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