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[NMusers] ISoP Data Standards at ACoP7

From: Radivojevic, Andrijana <>
Date: Thu, 20 Oct 2016 13:21:36 +0000

Population pharmacokinetic (popPK) analyses are performed regularly, and st=
and as a commonly-included component of regulatory submissions. Datasets us=
ed in such analyses are prepared and documented inconsistently, however, wi=
th varying degrees of quality, are often difficult to review (internally an=
d externally) and as such do not facilitate the development of precompetiti=
ve tools for process automation and data exploration.

A group of around 20 enthusiastic pharmacometricians and data programmers w=
as formed at the beginning of 2016 to address this situation. Sponsored by =
ISoP, the group envisions the development of common popPK data standards fo=
r interchange and analysis. Some of the benefits will include improved:

* consistency in pharmacometric datasets,

* quality (fewer errors),

* efficiency (automation of dataset preparation, facilitation of proj=
ect 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 exper=
tise to this initiative and will assist in its eventual integration with th=
eir system of standards. We intend to develop open-source companion tools t=
o 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 an=
yone with ideas that could facilitate achieving our goal and our overall vi=
sion to move the field of Pharmacometrics forward!

For more information, do not hesitate to contact Andrijana Radivojevic<mail=> (Novartis), or any other member of t=
he team: Justin Wilkins<> (Occams), Brian Corriga=
n<> (Pfizer), Ted Grasela<mailto:Ted.Grasel=> (Cognigen), Jill Fiedler-Kelly<mailto:jill.fiedler-kell=> (Cognigen), Murad Melhem<> (Amg=
en), Robert Fox<> (AstraZeneca), Huan Liu<=> (AstraZeneca), Jing Su<mailto:jing_su_at_merc=> (Merck), Neelima Thanneer<> (BMS), Ma=
ciej J Swat<> (DDMoRE), Peter Schaefer<mailto:pschae=> (Validated Cloud Applications), David Radtke<mailto:radtk=> (Eli Lilly), Henning Schmidt<mailto:henning.schmidt_at_in=> (IntiQuan), Christian Rasmussen<> (N=
ovo Nordisk), Warwick Benger<> (GSK), Jeff=
ry Florian<> (FDA), Scott Pivirotto<mailto=> (Metrum), Tim Bergsma<>=
 (Certara), Stuart Moodie<> (Eight =
Pillars), Liping Zhang<> (J&J), or simply join u=
s 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<

Received on Thu Oct 20 2016 - 09:21:36 EDT

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