The Data Standards Working Group within ISoP’s Standards and Practices Committee is comprised of approximately 25 scientists and programmers working towards a harmonized standard for datasets used in pharmacometric analysis.
The group was established in late 2015, and expects to publish a first draft standard for population pharmacokinetic datasets in the first half of 2017. Our 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.
An informal survey was conducted amongst representatives (pharmacometricians and data programmers) of 19 participating organizations in the Data Standards Working Group, in order to understand how pharmacometric data preparation is currently handled in practice. A total of 13 multinational pharmaceutical companies, 5 contract research organizations and a national regulatory agency responded, and were represented in the findings. You can find a high-level overview of the results below!
The Data Standards Working Group is led by Andrijana Radivojevic, and meets by TC twice a month. Want to join? Contact us!