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ISoP Data Standards @ ACoP7


Population pharmacokinetic (popPK) analyses are performed regularly, and stand as a commonly-included component of regulatory submissions. Datasets used in such analyses are prepared and documented inconsistently, however, with varying degrees of quality, are often difficult to review (internally and externally) and as such do not facilitate the development of precompetitive tools for process automation and data exploration.

A group of around 20 enthusiastic pharmacometricians and data programmers was formed at the beginning of 2016 to address this situation. Sponsored by ISoP, the group envisions the development of common popPK data standards for interchange and analysis. Some of the benefits will include improved:
• consistency in pharmacometric datasets,
• quality (fewer errors),
• efficiency (automation of dataset preparation, facilitation of project handover and on-boarding, enabling development of open-source tools for automatic graphical exploration), and
• regulatory compliance and audit readiness (enabling development of open-source tools for packaging data for submission).

The group has established close links with CDISC, who have lent their expertise to this initiative and will assist in its eventual integration with their system of standards. We intend to develop open-source companion tools to support the automation of dataset creation and checking. Once this first phase is complete, we intend to expand our focus to include PK-PD datasets.

On Tuesday, October 25, 5–6:30pm, we will have an open session at ACoP 7 in Bellevue. We intend to update the community on our progress and welcome anyone with ideas that could facilitate achieving our goal and our overall vision to move the field of Pharmacometrics forward!

For more information, do not hesitate to contact Andrijana Radivojevic (Novartis), or any other member of the team: Justin Wilkins (Occams), Brian Corrigan (Pfizer), Ted Grasela (Cognigen), Jill Fiedler-Kelly (Cognigen), Murad Melhem (Amgen), Robert Fox (AstraZeneca), Huan Liu (AstraZeneca), Jing Su (Merck), Neelima Thanneer (BMS), Maciej J Swat (DDMoRE), Peter Schaefer (Validated Cloud Applications), David Radtke (Eli Lilly), Henning Schmidt (IntiQuan), Christian Rasmussen (Novo Nordisk), Warwick Benger (GSK), Jeffry Florian (FDA), Scott Pivirotto (Metrum), Tim Bergsma (Certara), Stuart Moodie (Eight Pillars), Liping Zhang (J&J), or simply join us this Tuesday!

Andrijana Radivojevic, PhD
Principal Pharmacometrics Scientist
Novartis Pharmaceuticals Corporation
One Health Plaza, 135/108A
East Hanover, NJ 07936-1080
Phone +1 862 778-1152
Mobile +1 917 714-1215

Best Practices for Creating Population PK Data Sets