Michele,
As a volunteer with CDISC, I hope that I can help more. For pharmacodynamic (and other biomarkers), it can often depend on what your assay is. For target/receptor occupancy, the new CP (cell phenotyping) domain has lots of permissible fields to capture the assay complexity. If you share more information about your biomarker, I can help you map it to the correct domain.
(I would also love to collaborate on a short communication on this topic to help assay scientists better understand how to use the CDISC SDTM fields to help with setting up appropriate data transfer agreements from the beginning.)
Joleen
------------------------------
Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------
Original Message:
Sent: 11-08-2022 18:09
From: Michele Gunsior
Subject: CDISC SDTM terminology - general question
Hello BPMC community,
The new SDTM terminology doesn't seem to have a pharmacodynamic domain to capture PD data. The other domains don't quite fit -- I've used the LB domain in the past -- and I'm wondering what other approaches are being taken.
I'd love to hear your perspective.
Thanks, Michele
------------------------------
Michele Gunsior
Astria Therapeutics
Boston MA
The opinions expressed are my own and may not reflect those of my employer.
------------------------------