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ISoP Data Standards at ACoP7

From: Radivojevic, Andrijana <andrijana.radivojevic>
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=
he team: Justin Wilkins<mailto:justinwil
en), Robert Fox<
mailto:Huan.Liu> (Merck), Neelima Thanneer<mailto:neelima.thanneer
ciej J Swat<mailto:mjswat
e_david_b> (IntiQuan), Christian Rasmussen<mailto:chvr
ovo Nordisk), Warwick Benger<mailto:Warwick.J.Benger
ry Florian<mailto:Jeffry.Florian
 (Certara), Stuart Moodie<mailto:stuart.moodie
Pillars), Liping Zhang<mailto:LZhang11
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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