Evidence map›Paper›PMID 40467912›Full record

ArticlePharmaceutical research2025

Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling.

Arindom Pal, Khondoker Alam, Ethan Stier, Tycho Heimbach, Rodrigo Cristofoletti, Jozef Al-Gousous, Peter Langguth, Rebeka Žakelj, Tausif Ahmed, Susana Almeida and 6 more

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026
    Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Arindom PalDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, 20993, USA.
Khondoker AlamDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, 20993, USA.
Ethan StierOffice of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), White Oak, Building 75, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Tycho HeimbachMerck & Co., Inc., Rahway, NJ, USA.
Rodrigo CristofolettiCenter for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
Jozef Al-GousousPharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany.
Peter LangguthPharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany.
Rebeka ŽakeljLek Pharmaceuticals d.d., a Sandoz Company, Ljubljana, Slovenia.
Tausif AhmedBiopharmaceutics and Bioequivalence Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.
Susana AlmeidaInternational Generic and Biosimilar Medicines Association (IGBA), Geneva, Switzerland.
Jianghong FanDivision of Pharmacometrics (DPM), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), White Oak, Building 75, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Vidula KolhatkarDivision of Bioequivalence II (DBII), Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), White Oak, Building 75, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Paulo PaixãoEuropean Medicines Agency (EMA), Amsterdam, Netherlands.
Mohan Krishna RayeniBiopharmaceutics and IVIVC, Sandoz Development Center, Hyderabad, India.
Lei ZhangOffice of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), White Oak, Building 75, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Fang WuDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, 20993, USA. wufang3@gmail.com.ORCID http://orcid.org/0009-0009-1485-8386

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On October 12, 2023, the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on "Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development", which highlighted significant strides in physiologically based pharmacokinetic (PBPK) modeling, particularly its application in the regulatory decision-making processes. This manuscript provides a comprehensive overview from the second session of the workshop titled "PBPK Modeling to Evaluate Food Impact on Bioequivalence Supporting ICH M13A", focusing on the critical role of PBPK modeling to evaluate the influence of food on drug bioequivalence (BE). Presentations and panel discussions from this session addressed the application of PBPK modeling for potential biowaiver of certain fed BE studies, thereby enhancing drug development efficiency and reducing costs. Presented case studies highlighted that PBPK modeling can be used to recapitulate formulation-dependent food impact, assist in the selection of biopredictive dissolution method and provide support for justifying the waiver of fed BE studies. The discussions also explored advanced methodologies for simulating the gastrointestinal environment more accurately and the operational insights from companies integrating PBPK modeling into their drug development program. Challenges such as the need for robust model validation and the integration of biopredictive dissolution testing results into the PBPK model were emphasized. Overall, the workshop session underscored the burgeoning confidence in PBPK modeling as a tool to refine regulatory pathways and optimize drug product evaluations, support future advancements in the field and harmonization across different regulatory agencies.

Indexed as

Drugs, GenericFood-Drug InteractionsModels, BiologicalAdministration, OralDrug DevelopmentHumansPharmacokineticsTherapeutic EquivalencyUnited StatesUnited States Food and Drug AdministrationDrugs, GenericFood impactHarmonizationICH M13 APhysiologically based pharmacokinetic (PBPK) absorption modelingVirtual bioequivalence (VBE)

Identifiers

PMID40467912

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.