Presentation of data in report and SAS output [Regulatives / Guidelines]

posted by arl_stat – India, 2020-10-15 16:12 (103 d 01:35 ago) – Posting: # 22010
Views: 532

Dear All,

Greetings !!

FDA recommends not to round off the decimal places for confidence intervals.
So for NTI drugs, the Swt, Swr and 95% upper bound and point estimate should be presented upto 2 decimal places without rounding off.

If for Cmax, the 95% upper bound value is 0.0025 and if presented as 0.00, will the study can be considered as pass?

For analysis in SAS, should we present the values in 2 decimals or 4 decimals without rounding off?

As in above criteria, if we present the data in 2 decimal places, the study is pass.

Please guide.


Complete thread:

 Admin contact
21,314 posts in 4,446 threads, 1,489 registered users;
online 6 (0 registered, 6 guests [including 1 identified bots]).
Forum time: Tuesday 16:48 CET (Europe/Vienna)

Any one who considers arithmetical methods
of producing random digits is, of course,
in a state of sin.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz