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Informatics in Medical Product Regulation: The Right Drug at the Right Dose for the Right Patient

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Systems Medicine

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2486))

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Abstract

This chapter describes the role of regulatory medical product review in furthering precision medicine. Efficient data processing and appropriate analyses are needed to synthesize information and provide directions for use in a medical product label. We describe opportunities and challenges in outcome assessment through informatics, as bioengineered therapeutics are increasingly developed for the unmet needs of molecularly defined diseases. Data submission requirements and analytic principles are outlined, and regulatory resources and foundational law and statute are cited for the reader.

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Notes

  1. 1.

    Unless a single well-characterized model exists.

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Acknowledgments

The authors acknowledge Jane Bai, Yun Wang, and Tejas Patel for their insightful review on the manuscript.

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Authors and Affiliations

  1. Paraclete Professionals, LLC, Clarksville, MD, USA

    Eileen Navarro Almario

  2. Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Anna Kettermann

  3. Biomedical Informatics and Regulatory Review Science, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Vaishali Popat

Authors
  1. Eileen Navarro Almario
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  2. Anna Kettermann
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  3. Vaishali Popat
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Corresponding author

Correspondence to Eileen Navarro Almario .

Editor information

Editors and Affiliations

  1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA

    Jane P.F. Bai

  2. School of Medicine and Health Sciences, University of North Dakota, Grand Forks, ND, USA

    Junguk Hur

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Disclaimer: This chapter reflects the views of the authors and should not be construed to represent FDA’s views or policies.

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Almario, E.N., Kettermann, A., Popat, V. (2022). Informatics in Medical Product Regulation: The Right Drug at the Right Dose for the Right Patient. In: Bai, J.P., Hur, J. (eds) Systems Medicine. Methods in Molecular Biology, vol 2486. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-2265-0_14

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  • DOI: https://doi.org/10.1007/978-1-0716-2265-0_14

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-2264-3

  • Online ISBN: 978-1-0716-2265-0

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