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Updated: Jul 26, 2025

Errors as a Means of Reducing Impulsive Food Choice

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Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.

Filippos Kesisoglou¹, Sumit Basu², Tejashree Belubbi³

¹Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA. Filippos_kesisoglou@merck.com.

The AAPS Journal

|June 15, 2023

Summary

Most repeat drug-food interaction studies show minimal changes in food effect, regardless of formulation adjustments. Physiologically based pharmacokinetic (PBPK) modeling can help predict outcomes, suggesting case-by-case evaluations for these studies.

Keywords:

PBPK bioequivalence drug-food interaction food effect modeling and simulation

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Area of Science:

Pharmacokinetics and Drug Development
Regulatory Science

Background:

Current guidelines mandate early and pivotal food effect studies for drug-food interactions.
Repeated food effect studies are common in drug development, but data is scarce.
Study waivers are limited to BCS class 1 drugs.

Purpose of the Study:

To compile data on repeated food effect studies across pharmaceutical companies.
To provide recommendations for the conduct of these studies.
To analyze the impact of formulation changes on food effect.

Main Methods:

Compilation of a dataset from 54 repeated food effect studies.
Analysis of changes in food effect and their relationship to formulation changes.
Demonstration of physiologically based pharmacokinetic (PBPK) model application for future formulations.

Main Results:

Most repeat food effect studies (54 collected) showed no meaningful differences in food effect assessment.
Observed changes in food effect were seldom greater than twofold.
No clear link was found between formulation changes and alterations in food effect, suggesting compound properties are key.

Conclusions:

Repeat food effect studies often yield similar results to initial assessments.
Physiologically based pharmacokinetic (PBPK) models, once validated, can be applied to new formulations.
Recommendations favor a case-by-case approach for repeat food effect studies, integrating all evidence including PBPK modeling.