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Oct 25, 2018

Data Standards for Model-Informed Drug Development: an ISoP Initiative

Abstract

Analysis datasets are fundamental components of pharmacometric analyses and their quality and readiness highly correlate with the efficiency and impact of pharmacometrics deliverables overall [1]. Despite this, structures of datasets vary widely. This article introduces the activities of International Society of Pharmacometrics (ISoP) Data Standards Group towards establishing standards for pharmacometric datasets. The ultimate goal is to reduce the time required to specify, implement and review datasets, and to facilitate portability within and across organizations.

By Andrijana Radivojevic, Brian Corrigan, Nicholas Downie, Robert Fox, Jill Fiedler-Kelly, Huan Liu, Murad Melhem  David Radke, Peter Schaefer, Jing Su, Maciej J Swat, Nathan S Teuscher, Neelima Thanneer, Alice Zong, Justin J Wilkins

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