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What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing

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Abstract

Model-informed precision dosing (MIPD) is modeling and simulation in healthcare to predict the drug dose for a given patient based on their individual characteristics that is most likely to improve efficacy and/or lower toxicity in comparison to traditional dosing. This paper describes the background and status of MIPD and the activities at the 1st Asian Symposium of Precision Dosing. The theme of the meeting was the question, “What does it take to make MIPD common practice?” Formal presentations highlighted the distinction between genetic and non-genetic sources of variability in drug exposure and response, the use of modeling and simulation as decision support tools, and the facilitators to MIPD implementation. A panel discussion addressed the types of models used for MIPD, how the pharmaceutical industry views MIPD, ways to upscale MIPD beyond academic hospital centers, and the essential role of healthcare professional education as a way to progress. The meeting concluded with an ongoing commitment to use MIPD to improve patient care.

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Acknowledgements

Finance from Inje University and Certara was provided to support the symposium. The authors are grateful to Ms. (Emma) Si Yeon Nam from the Pharmacogenomics Research Center at Inje University for her efforts in organizing the symposium, and to all the attendees who made the day very informative and enjoyable.

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Authors and Affiliations

  1. Certara, 100 Overlook Center, Suite 101, Princeton, New Jersey, 08540, USA

    Thomas M. Polasek, Amin Rostami-Hodjegan & Masoud Jamei

  2. Centre for Medicines Use and Safety, Monash University, Melbourne, Australia

    Thomas M. Polasek

  3. Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK

    Amin Rostami-Hodjegan & Adam S. Darwich

  4. Department of Pharmacology, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Dong-Seok Yim

  5. Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea

    Howard Lee

  6. Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, South Korea

    Howard Lee

  7. Janssen Research and Development, Lower Gwynedd Township, Pennsylvania, USA

    Holly Kimko

  8. Korea Advanced Institute of Advanced Technology, Daedoek Innopolis, Daejeon, South Korea

    Jae Kyoung Kim

  9. Department of Pharmacology and Clinical Pharmacology, Pharmacogenomics Research Center, Inje University College of Medicine, Busan, Republic of Korea

    Phuong Thi Thu Nguyen & Jae-Gook Shin

  10. Faculty of Pharmacy, Haiphong University of Medicine and Pharmacy, Haiphong, Vietnam

    Phuong Thi Thu Nguyen

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  1. Thomas M. Polasek
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Correspondence to Thomas M. Polasek.

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Conflict of Interest

Thomas M. Polasek, Amin Rostami-Hodjegan, and Masoud Jamei are employees of Certara. Certara makes modeling and simulation software, including one type of PBPK platform (Simcyp®), which is used by the pharmaceutical industry for drug development. All other authors declare that they have no conflicts of interest.

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Polasek, T.M., Rostami-Hodjegan, A., Yim, DS. et al. What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing. AAPS J 21, 17 (2019). https://doi.org/10.1208/s12248-018-0286-6

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