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Utilisation of Pharmacokinetic-Pharmacodynamic Modelling and Simulation in Regulatory Decision-Making

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Abstract

Modelling and simulation (M&S) play an important role in regulatory decision-making that affects both the public and industry. Technological advances in various fields related to drug development call for more focus on ways to optimise current drug development practices. Recognition of the potential of M&S by regulatory agencies inevitably has a substantial impact on drug development. The objective of the current review is to present the various regulatory initiatives for application of M&S to clinical drug development. The relevant parts of the various recommendations issued by the US Food and Drug Administration (FDA), via guidance documents and advisory committee meeting proceedings, are highlighted. Application of M&S to a variety of activities, such as integrating pharmacokinetic-pharmacodynamic knowledge across a new drug application and designing efficient trials, is discussed. Some of the challenges that pharmaceutical institutions currently face when implementing M&S projects, such as team structure, communication with regulators, training and time constraints, are also presented, and solutions are, proposed.

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Acknowledgements

The views expressed in this article are those of the authors and do not reflect the official policy of the FDA. No official endorsement by the FDA is intended or should be inferred.

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Authors and Affiliations

  1. Pharmacometrics, US Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, 1451 Rockville Pike, Rockville, Room 5088, HFD-860, Maryland, 20852, USA

    Jogarao V. S. Gobburu

  2. Division of Pharmaceutical Evaluation - 1, United States Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Rockville, Maryland, USA

    Patrick J. Marroum

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  1. Jogarao V. S. Gobburu
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Correspondence to Jogarao V. S. Gobburu.

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Gobburu, J.V.S., Marroum, P.J. Utilisation of Pharmacokinetic-Pharmacodynamic Modelling and Simulation in Regulatory Decision-Making. Clin Pharmacokinet 40, 883–892 (2001). https://doi.org/10.2165/00003088-200140120-00001

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