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CDISC SDTM for PK for CAR T therapies measure as vector copies/gDNA

  • 1.  CDISC SDTM for PK for CAR T therapies measure as vector copies/gDNA

    This message was posted by a user wishing to remain anonymous
    Posted 10-15-2024 20:50
    This message was posted by a user wishing to remain anonymous

    Hi Community

    I am new to CDISC SDTM domains.  I am wondering which domains can be used for PK that uses vector copies number/gDNA to measure cellular kinetics in CAR T cells. Would this go under PC domain?

    Thank you in advance!



  • 2.  RE: CDISC SDTM for PK for CAR T therapies measure as vector copies/gDNA

    Posted 10-16-2024 10:00
    Hello

    If the measurements go under PK and exposure they should be databased in PC domain i.e. pc and adpc (ADaM) datasets. 
    The other option if measurements are related to pharmacogenomics eg measurements of DNA/RNA and changes in their content/amount, they can also be considered in PG or pF domains (pharmacogenomics or pharmacogenomics findings) and datasets pg and pf, ADaM datasets adpg or adpf. 
    Considering that it's not innate genomics I would think pf and adpf are more appropriate.
    It would depend on the exact nature of your data and how you want to position them - as PK information and calculate exposure from them or as pharmacogenomics findings.

    You can join the CDISC community for free https://www.cdisc.org/ and get information about all datasets from there as well as access the CDISC library.

    Galina Bernstein