Evidence map›Paper›PMID 40140126›Full record

ArticlePharmaceutical research2025

PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.

Fang Wu, Eleftheria Tsakalozou, Gilbert J Burckart, Rebeka Žakelj, Lu Gaohua, Kazuko Sagawa, Viera Lukacova, Siva Vaithiyalingam, Jianghong Fan, Nikoletta Fotaki and 2 more

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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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

12 authors.

Fang WuOffice 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, USA.
Eleftheria TsakalozouOffice 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, USA.
Gilbert J BurckartOffice of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA.
Rebeka ŽakeljLek Pharmaceuticals d.d., a Sandoz Company, Ljubljana, Slovenia.
Lu GaohuaBristol Myers Squibb, Princeton, NJ, USA.
Kazuko SagawaPfizer Global Research and Development, Groton, CT, USA.
Viera LukacovaSimulations Plus, Inc., Lancaster, CA, USA.
Siva VaithiyalingamRegulatory Affairs, Cipla LTD, Warren, NJ, USA.
Jianghong FanOffice of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, MD, USA.
Nikoletta FotakiUniversity of Bath, Bath, UK.
Nikunjkumar PatelCertara UK Ltd, Sheffield, S1 2BJ, UK.
Lanyan FangOffice 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, USA. Lanyan.Fang@fda.hhs.gov.ORCID http://orcid.org/0000-0001-5378-2948

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This report summarizes the proceedings for Session 3 of the one-day public workshop entitled "Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development" a jointly sponsored workshop by U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023. The theme of this session was the application and relevant considerations for PBPK modeling in supporting bioavailability (BA) and BE assessment in pediatric populations. The takeaway message from this session was that PBPK modeling can support relative BA and BE assessment in pediatrics since such studies are generally performed in adults or healthy subjects. PBPK absorption modeling can incorporate characteristics of the drug substance and formulation as well as pediatric physiology to assess the potential differences in absorption of different formulations in pediatrics for new and generic drugs. It is necessary to consider the totality of data and use all available evidence integrated into a mechanistic PBPK model to support decision-making. Global research efforts are needed to bridge critical data gaps.

Indexed as

Drugs, GenericModels, BiologicalAdministration, OralBiological AvailabilityChildDrug DevelopmentHumansTherapeutic EquivalencyUnited StatesUnited States Food and Drug AdministrationDrugs, GenericAbsorptionPBPK modelingPediatricsVirtual bioequivalence

Identifiers

PMID40140126
PMCPMC12158840

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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.