Evidence map›Paper›PMID 40969885›Full record

ArticleACS pharmacology & translational science2025

Cross-Species Extrapolation of Neonatal Fc Receptor (FcRn) Binding Affinity to Predict Monoclonal Antibody Pharmacokinetics in Humans Using Physiologically Based Pharmacokinetic Modeling (PBPK): Are We There Yet?

Salih Benamara, Carla Troisi, Florence Gattacceca, Erik Sjögren, Laurent Nguyen, Donato Teutonico

Abstract read
In one paragraph

Article in ACS pharmacology & translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

6 authors.

Salih BenamaraDevelopment Pharmacometrics, Translational Medicine Unit, Sanofi, 94400 Vitry-sur-Seine, France.
Carla TroisiDevelopment Pharmacometrics, Translational Medicine Unit, Sanofi, 94400 Vitry-sur-Seine, France.
Florence GattaccecaComputational Pharmacology and Clinical Oncology (COMPO) Unit, Inria Sophia Antipolis-Méditerranée, Cancer Research Center of Marseille, Inserm UMR1068, CNRS UMR7258, Aix Marseille University UM105, 13385 Marseille, France.ORCID https://orcid.org/0000-0002-4944-8063
Erik SjögrenPharmetheus AB 753 19 Uppsala, Sweden.
Laurent NguyenDevelopment Pharmacometrics, Translational Medicine Unit, Sanofi, 94400 Vitry-sur-Seine, France.
Donato TeutonicoDevelopment Pharmacometrics, Translational Medicine Unit, Sanofi, 94400 Vitry-sur-Seine, France.ORCID https://orcid.org/0000-0003-4931-410X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Physiologically based pharmacokinetic (PBPK) modeling is a useful tool during drug development due to its ability to extrapolate pharmacokinetics (PK) between species and populations. For monoclonal antibodies (mAbs), these models can be used to support dose selection, especially for first-in-human (FIH) trials. In the PBPK model for biologics in the software PK-Sim, salvaging from endosomal degradation via the neonatal fragment crystallizable receptor (FcRn) is a critical process for the systemic clearance of mAbs. However, high variability is associated with in vitro measurements of the dissociation constant (

Indexed as

first-in humanmonoclonal antibodyneonatal Fc receptorPBPKtranslational pharmacokinetics

Identifiers

PMID40969885
PMCPMC12441845

What OpenQuestion holds

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Registered trials

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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.