Dear colleagues,
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).
https://docs.google.com/document/d/1MUGiU6U-52pw_nojPD5lNR9PrTxoEeM3IQFLWeDOM6A/edit?usp=sharing
Thanks for your help with this!
For any questions or difficulties with access, feel free to contact me directly.
Best regards,
Andrijana Radivojevic, PhD
Associate Director, Pharmacometrics
T +1 862 778-1152
M +1 917 714-1215
[email protected]<mailto:[email protected]>
Novartis Pharmaceuticals Corporation
One Health Plaza, 135/108A
East Hanover, NJ 07936-1080
USA