PC PP domains for CDISC submission [Regulatives / Guidelines]

posted by Abc123 – India, 2017-05-29 14:45 (2521 d 17:55 ago) – Posting: # 17425
Views: 5,810

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:-)

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