Presentation of data in report and SAS output [Regulatives / Guidelines]
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.
- bioequivalence criteria for NTID Biostats 2018-03-29 12:39 [Regulatives / Guidelines]