## 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

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Bioequivalence and Bioavailability Forum |  Admin contact
19,488 posts in 4,135 threads, 1,336 registered users;
online 16 (1 registered, 15 guests [including 9 identified bots]).
Forum time (Europe/Vienna): 11:09 CEST

No rational argument will have a rational effect on a man
who does not want to adopt a rational attitude.    Karl R. Popper

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
Ing. Helmut Schütz