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Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

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Abstract

The number of modeling and simulation applications, including physiologically based pharmacokinetic (PBPK) models, physiologically based biopharmaceutics modeling (PBBM), and empirical models, has been constantly increasing along with the regulatory acceptance of these methodologies. While aiming at minimizing unnecessary human testing, these methodologies are used today to support the development and approval of novel drug products and generics. Modeling approaches are leveraged today for assessing drug-drug interaction, informing dose adjustments in renally or hepatically impaired patients, perform dose selection in pediatrics and pregnant women and diseased populations, and conduct biopharmaceutics-related assessments such as establish clinically relevant specifications for drug products and achieve quality assurance throughout the product life cycle. In the generics space, PBPK analyses are utilized toward virtual bioequivalence assessments within the scope of alternative bioequivalence approaches, product-specific guidance development, and food effect assessments among others. Case studies highlighting the evolving and expanding role of modeling and simulation approaches within the biopharmaceutics space were presented at the symposium titled “Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers – Chemical Entities” and Prologue “PBPK/PBBM to inform the Bioequivalence Safe Space, Food Effects, and pH-mediated DDIs” at the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Annual Meeting in Boston, MA, on October 16–19, 2022, and are summarized here.

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Acknowledgements

The authors thank Dr. Vaishali Sahasrabudhe for helping organize the session.

Funding

AbbVie provided financial support for the studies and participated in the study design, study conduct, and analysis and interpretation of data and the writing, review, and approval of the manuscript. These efforts were led by Mohamed-Eslam F. Mohamed from AbbVie.

Others’ work reported in this article is not funded or sponsored.

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Authors and Affiliations

  1. Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland, USA

    Eleftheria Tsakalozou

  2. Clinical Pharmacology, AbbVie, North Chicago, Illinois, 60064, USA

    Mohamed-Eslam F. Mohamed

  3. Certara UK, Simcyp Division, Sheffield, UK

    Sebastian Polak

  4. Jagiellonian University Medical College, Krakow, Poland

    Sebastian Polak

  5. Pharmaceutical Sciences, MRL, Merck & Co., Inc, Rahway, New Jersey, 07065, USA

    Tycho Heimbach

Authors
  1. Eleftheria Tsakalozou
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  2. Mohamed-Eslam F. Mohamed
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  3. Sebastian Polak
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  4. Tycho Heimbach
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Contributions

ET, M-EFM, SP, and TH wrote and reviewed the manuscript.

Corresponding author

Correspondence to Eleftheria Tsakalozou.

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Conflict of Interest

Mohamed-Eslam F. Mohamed is an employee and shareholder of AbbVie, Inc. All other authors declared no competing interests for this work.

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The opinions expressed in the manuscript are those of the authors and should not be interpreted as the position of their organizations/employers. The opinions expressed in the manuscript are those of the authors and should not be interpreted as the position of the US Food and Drug Administration.

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Tsakalozou, E., Mohamed, ME.F., Polak, S. et al. Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary. AAPS J 25, 96 (2023). https://doi.org/10.1208/s12248-023-00862-x

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