Data standards for model-informed drug development: an ISoP initiative
Analysis datasets are fundamental components of pharmacometric analyses and their quality and readiness highly correlate with the efficiency and impact of pharmacometrics deliverables overall . 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.
Data in pharmacometrics
The last two decades have seen remarkable changes in the expectations for data used in decision-making, both in drug development and in the clinic, particularly with respect to the speed of collection, analysis, and communication of results. In parallel, sources of data have grown exponentially in type and quantity, challenging our ability to utilize the available information in a cogent...
The authors thank and acknowledge the contributions of ISoP Data Standards initiative group members: Ted Grasela, Jeffry Florian, Timothy Bergsma, Warwick Benger, Christian Rasmussen, Henning Schmidt, Liping Zhang, Scott Pivirotto, Stuart Pearce, Pragathi Kotha Venkata, Vishak Subramoney and Ana Henry, as well as René Bruno for his feedback on the manuscript.
Compliance with ethical standards
Conflict of interest
A.R. is an employee of IntiGrowth LLC, B.C. of Pfizer Global Research, N.D. of Bayer AG, R.F. and H.L. of AstraZeneca, J.F.-K. of Cognigen Corporation (a SimulationsPlus company), M.M. of Amgen Inc., D.R. of Eli Lilly and Company, P.S. of VCA-Plus, J.S. of Merck, M.J.S. of Simcyp (a Certara company), N.S.T. of Certara, N.T. of Bristol-Myers Squibb, A.Z. of Janssen Pharmaceutical Companies of Johnson & Johnson, J.J.W. of Occams.
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