The Data Standards Working Group within ISoP’s Standards and Practices Committee has been working on the development of a standard for population pharmacokinetic (PK) datasets. Medium and long-term goals are to bring these standards into alignment with the requirements of CDISC (the Clinical Data Interchange Standards Consortium) and to extend them to pharmacodynamics (PD).
The draft standard is now open for review and your input until 31-Dec-2017. The final release of a standard, anticipated in Q1 2018, will consist of implementation guide and guidance for imputations of missing data. Please make suggestions and add comments directly to this document, using “Suggesting” mode (top right-hand corner of the Google Docs interface).
Thanks for your help with this!
For any questions or difficulties with access, feel free to contact me directly.
Andrijana Radivojevic, PhD
Associate Director, Pharmacometrics
T +1 862 778-1152
M +1 917 714-1215
Novartis Pharmaceuticals Corporation
One Health Plaza, 135/108A
East Hanover, NJ 07936-1080