We would like to submit PP domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions for a NCA analysis.
We have seen in the SDTM and SEND implementation guide that it's recommended to report "information pertaining to all parameters (e.g. number of exponents, model weighting) should be submitted in either SUPPPP dataset or define".
Do any of them do this for SDTM/SEND PK datasets and if so what parameters they indicate in SUPPPP ? Do you use PK submit for that ?
Thanks for your help,