Evidence map›Paper›PMID 26518984›Full record

ArticleBritish journal of clinical pharmacology2016

Prediction of human fetal pharmacokinetics using ex vivo human placenta perfusion studies and physiologically based models.

Maïlys De Sousa Mendes, Deborah Hirt, Cécile Vinot, Elodie Valade, Gabrielle Lui, Claire Pressiat, Naïm Bouazza, Frantz Foissac, Stephane Blanche, Minh Patrick Lê and 4 more

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 8% of its field
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

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Article
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  4. Review
  5. Article
  6. Article
  7. Models of Endocrine-Disrupting Effects: Human Placental Steroidogenesis.Basic & clinical pharmacology & toxicology · 2025
    Review
  8. Article
  9. Review
  10. Review
  11. Placental drug transport and fetal exposure during pregnancy is determined by drug molecular size, chemistry, and conformation.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
  12. Article
  13. Article
  14. Review
  15. Article
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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

14 authors at 7 institutions in 1 country.

Maïlys De Sousa MendesEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Deborah HirtEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Cécile VinotEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Elodie ValadeEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Gabrielle LuiEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Claire PressiatEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Naïm BouazzaEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Frantz FoissacEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Stephane BlancheEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Minh Patrick LêAP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Pharmacologie, 75018, Paris, France.
Gilles PeytavinAP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Pharmacologie, 75018, Paris, France.
Jean-Marc TreluyerEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Saik UrienEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Sihem BenaboudEA08: Evaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, Unité de Recherche Clinique Paris Centre, 75006, Paris, France.
Hôpital Broca · FRHôpital Bichat-Claude-Bernard · FRHôpital Cochin · FRHôpital Necker-Enfants Malades · FRHôtel-Dieu de Paris · FRInserm · FRUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsPregnant women can be exposed to numerous drugs during the gestational period. For obvious ethical reasons, in vivo studies of fetal exposure to drugs are limited. Information about the transplacental transfer of drugs prior to their administration to pregnant women would be highly useful. In the present study, a novel approach was developed quantitatively predict or to predict the fetal exposure to drugs administered to the mother quantitatively.

methodsTransplacental parameters estimated from ex vivo human placenta perfusion experiments were implemented in pregnancy-physiologically based pharmacokinetic (p-PBPK) models in order to predict fetal PK. Thereafter, fetal PK profiles for two antiretroviral drugs, tenofovir (TFV) and emtricitabine (FTC) were simulated. These predictions were then compared to observed cord blood concentrations, to validate these models.

resultsParameters obtained from the ex vivo experiments enabled a good prediction of observed cord blood concentrations without additional a scaling factor. Moreover, a sensitivity analysis showed that fetal predictions were sensitive to changes in transplacental parameters values obtained ex vivo.

conclusionThe integration of ex vivo human placental perfusion parameters in a p-PBPK model should be a promising new approach for predicting human fetal exposure to xenobiotics.

Indexed as

Models, BiologicalAnti-HIV AgentsComputer SimulationEmtricitabineFemaleFetal BloodFetusHumansMaternal-Fetal ExchangePerfusionPlacentaPlacental CirculationPredictive Value of TestsPregnancyTenofovirAnti-HIV AgentsEmtricitabineTenofoviremtricitabinefetusPBPKpharmacokineticspregnancytenofovir

Identifiers

PMID26518984
PMCPMC4799920
OpenAlexW1888510252

What OpenQuestion holds

Textmetadata
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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.