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Informatics: The fuel for pharmacometric analysis

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Abstract

The current informal practice of pharmacometrics as a combination art and science makes it hard to appreciate, the role that informatics can and should play in the future of the discipline and to comprehend the gaps that exist because of its absence. The development of pharmacometric informatics has important implications for expediting decision making and for improving the reliability of decisions made in model-based development. We argue that well-defined informatics for pharmacometrics can lead to much needed improvements in the efficiency, effectiveness, and reliability of the pharmacometrics process.

The purpose of this paper is to provide a description of the pervasive yet often poorly appreciated role of informatics in improving the process of data assembly, a critical task in the delivery of pharmacometric analysis results. First, we provide a brief description of the pharmacometric analysis process. Second, we describe the business processes required to create analysis-ready data sets for the pharmacometrician. Third, we describe selected informatic elements required to support the pharmacometrics and data assembly processes. Finally, we offer specific suggestions for performing a systematic analysis of existing challenges as an approach to defining the next generation of pharmacometric informatics.

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Authors and Affiliations

  1. Cognigen Corporation, 395 Youngs Road, 14221-5831, Buffalo, NY

    Thaddeus H. Grasela, Jill Fiedler-Kelly, Brenda Cirincione, Darcy Hitchcock, Kathleen Reitz & Susanne Sardella

  2. Department of Philosophy, University of Buffalo, 14260, Buffalo, NY

    Barry Smith

Authors
  1. Thaddeus H. Grasela
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  2. Jill Fiedler-Kelly
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  3. Brenda Cirincione
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  4. Darcy Hitchcock
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  5. Kathleen Reitz
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  6. Susanne Sardella
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  7. Barry Smith
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Correspondence to Thaddeus H. Grasela.

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Published: March 9, 2007

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Grasela, T.H., Fiedler-Kelly, J., Cirincione, B. et al. Informatics: The fuel for pharmacometric analysis. AAPS J 9, 8 (2007). https://doi.org/10.1208/aapsj0901008

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  • DOI: https://doi.org/10.1208/aapsj0901008

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