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01-08-2018 | Current Opinion

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

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

Published in: Clinical Pharmacokinetics | Issue 8/2018

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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Title: Industry Perspective on Standardizing Food-Effect Studies for New Drug Development
Authors: Patrick J. Marroum
Silpa Nuthalapati
Apurvasena Parikh
Mohamad Shebley
David Hoffman
Jiuhong Zha
Amit Khatri
Walid M. Awni
Publication date: 01-08-2018
Publisher: Springer International Publishing
Published in: Clinical Pharmacokinetics / Issue 8/2018
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI: https://doi.org/10.1007/s40262-018-0630-0

At a glance: The STEP trials

Springer Medicine

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

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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