1 reply to this topic

[spic]

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,

 

 

[Simon Davis]

We cannot speak for our users as to how commonly this is done in practice.  However If you do need to submit this information, then you could create a new variable name and new variable label and build a SUPPPP domain.

 

(for others following this thread, the SUPP—domain’s main use is to include  any non-standard (SDTM) variables.

Example: in SDTM, PP domain does not have an exclusion variable “PPEXCLFL”, but users sometimes need to exclude a “PP” value from descriptive stats but would still like to report it in the PP domain, in this case you would build a SUPPPP domain as shows in the screen below:

 

STUDYID   :   STUDYID

RDOMAIN  :    "PP"

USUBJID    :    SUBJID

IDVAR        :    "PPSEQ"

IDVARVAL  :   PP.PPSEQ (of the appropriate parameter)

QNAM        :   "PPWGHT"

QLABEL     :   "Weighting for lambdaz"

QVAL         :    "Uniform weighting"

QORIG      :     QEVAL

   Simon

Attached Thumbnails

• 

Edited by Simon Davis, 16 December 2019 - 03:54 PM.