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RegisterPC PP domains for CDISC submission [Regulatives / Guidelines]
Hello!
This is regarding the new CDISC requirement.
I currently submit the plasma concentration data and the pharmacokinetic (Pk) data in .xpt formats for Bioequivalence studies.
Is it appropriate to continue submitting these two datasets in .xpt formats, or do I have to submit it as an SDTM/ADaM domain (PC and PP)?
Thank you in advance
This is regarding the new CDISC requirement.
I currently submit the plasma concentration data and the pharmacokinetic (Pk) data in .xpt formats for Bioequivalence studies.
Is it appropriate to continue submitting these two datasets in .xpt formats, or do I have to submit it as an SDTM/ADaM domain (PC and PP)?
Thank you in advance
Complete thread:
- PC PP domains for CDISC submissionAbc123 2017-05-29 12:45 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- ADaM and SDTM files submission question for Generic products Shuanghe 2017-07-24 18:53
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
Ing. Helmut Schütz