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Industry Perspective on Standardizing Food-Effect Studies for New Drug Development

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Abstract

Investigating the effect of food on bioavailability during the development of an oral drug product is of prime importance because it has major implications on the study design of the clinical trials and dosing and administration recommendations. For modified-release formulations that exhibit dose dumping when administered with food, this may result in clinical concerns around safety and efficacy. In this article, we provide an overview of the various considerations in our opinion that impact the design and conduct of food-effect studies. We summarize the various recommendations from the different regulatory agencies and provide specific suggestions on study conduct in terms of statistical design, timing of studies, subject selection, and type and caloric content of the meal. We also discuss the role of modeling and simulation. Finally, we present an interpretation of the results of food-effect studies in addition to dosing and labeling recommendations in relation to regulatory guidance documents.

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Acknowledgements

The authors thank project manager Mary Knudson, PharmD of AbbVie for project management support and Mia DeFino, MS, a freelance medical writer under contract with AbbVie for medical writing support.

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No funding was received for the preparation of this article.

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Authors and Affiliations

  1. Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064-1802, USA

    Patrick J. Marroum, Silpa Nuthalapati, Apurvasena Parikh, Mohamad Shebley, David Hoffman, Jiuhong Zha, Amit Khatri & Walid M. Awni

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  1. Patrick J. Marroum
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  2. Silpa Nuthalapati
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Correspondence to Patrick J. Marroum.

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Patrick J. Marroum, Silpa Nuthalapati, Apurvasena Parikh, Mohamad Shebley, David Hoffman, Jiuhong Zha, Amit Khatri, and Walid M. Awni are employees of AbbVie and may hold AbbVie stock or stock options.

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Marroum, P.J., Nuthalapati, S., Parikh, A. et al. Industry Perspective on Standardizing Food-Effect Studies for New Drug Development. Clin Pharmacokinet 57, 901–909 (2018). https://doi.org/10.1007/s40262-018-0630-0

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