ReviewThe AAPS journal2008
Current methods for predicting human food effect.
Review in The AAPS journal, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed.
- A 2-Part, Open-Label, Phase 1 Bioequivalence and Food-Effect Study of Ubrogepant in Healthy Adult Participants.Clinical pharmacology in drug development · 2025Trial
- Single-Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK-788) in Healthy Volunteers: Low-Fat Meal Effect and Relative Bioavailability of 2 Capsule Products.Clinical pharmacology in drug development · 2021Trial
- The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers.Clinical pharmacology in drug development · 2021Trial
- Effects of High- and Low-Fat Meals on the Pharmacokinetics of Ozanimod, a Novel Sphingosine-1-Phosphate Receptor Modulator.Clinical pharmacology in drug development · 2018Trial
- Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability.Drug design, development and therapy · 2017Trial
- Population pharmacokinetic modeling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and sporanox capsule formulations in healthy subjects in fed and fasted states.Antimicrobial agents and chemotherapy · 2015Trial
- Development of population pharmacokinetics model of icotinib with non-linear absorption characters in healthy Chinese volunteers to assess the CYP2C19 polymorphism and food-intake effect.European journal of clinical pharmacology · 2015Trial
- Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption.PloS one · 2015Trial
- Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound.AAPS PharmSciTech · 2013Trial
- Considerations for the dynamic role of bile acids during oral drug discovery and development.npj drug discovery · 2026Review
- Machine learning to predict food effects during drug development: a comprehensive review.Journal of cheminformatics · 2025Review
- Solubility-Limited Absorption Identified by a Simplified PBPK Model for the Prediction of Positive Food Effect for BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Evaluation of Solubility-Limited Absorption as a Surrogate to Predicting Positive Food Effect of BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Safety, tolerability, and pharmacokinetics of faldaprevir after single increasing doses in healthy subjects.Frontiers in pharmacology · 2025Article
- Food Interactions Observed in a Pharmacokinetic Investigation Comparing Two Marketed Cold Preparations (BNO1016 and ELOM-080) after Administration to Beagle Dogs - A Pilot Study.Planta medica · 2023Article
- Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development.Pharmaceutical research · 2023Review
- Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms.The AAPS journal · 2022Review
- Assessing Food Effects on Oral Drug Absorption Based on the Degree of Renal Excretion.The AAPS journal · 2021Article
- Food (Matrix) Effects on Bioaccessibility and Intestinal Permeability of Major Olive Antioxidants.Foods (Basel, Switzerland) · 2020Article
- Biliary Excretion-Mediated Food Effects and Prediction.The AAPS journal · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Food can impact the pharmacokinetics of a drug product through several mechanisms, including but not limited to, enhancement in drug solubility, changes in GI physiology, or direct interaction with the drug. Significant food effects complicate development of new drugs, especially when clinical plans require control and/or monitoring of food intake in relation to dosing. The prediction of whether a drug or drug product will show a human food effect is challenging. In vitro models which consider physical-chemical properties can classify the potential for a compound to demonstrate a positive, negative or no food effect, and may be appropriate for screening compounds at early stages of drug discovery. When comparing various formulations, dissolution tests in biorelevant media can serve as a predictor of human drug performance under fasted and fed conditions. Few in vivo models exist which predict the magnitude of change in pharmacokinetic parameters in humans when dosing in the presence of food, with the dog appearing to be the most studied species for this purpose. Control of gastric pH, as well as the amount and composition of the fed state in dogs are critical parameters to improving the predictability of the dog overall as a food effect model. No single universal model is applicable for all drugs at all stages of drug development. One or more models may be required depending whether the goal is to assess potential for a food effect, determine the magnitude of change in pharmacokinetic parameters in the fed/fasted state, or whether formulation efforts have the ability to mitigate an observed food effect.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.