Hi everyone,
I have recently started working on the CDISC Files preparation for bioequivalence studies (BE) (For FDA submission).
I wrote required SAS codes to generate all the SDTM and ADaM required domains. I have tested these codes against related CDISC and FDA guidelines for different BE studies using SAS OnDemand for Academics_ SAS studio.
My questions are the following:
1- Can we use SAS OnDemand for Academics_ SAS studio to generate xpt files. If yes, should we validate this software and/ or SAS codes? or validating xpt files using (PINNACLE 21) is enough.
2-If the answer for the first section of question1 is no, can we use SAS 9.4?
Many Thanks in advance
Regards