Evidence map›Paper›PMID 39558864›Full record

ArticleCPT: pharmacometrics & systems pharmacology2024

Investigation of a fully mechanistic physiologically based pharmacokinetics model of absorption to support predictions of milk concentrations in breastfeeding women and the exposure of infants: A case study for albendazole.

Susan Cole, Maria Malamatari, Andrew Butler, Mahnoor Arshad, Essam Kerwash

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

5 authors.

Susan ColeMedicines and Healthcare Products Regulatory Agency, London, UK.ORCID 0000-0002-4582-6231
Maria MalamatariMedicines and Healthcare Products Regulatory Agency, London, UK.ORCID 0000-0003-1144-0629
Andrew ButlerMedicines and Healthcare Products Regulatory Agency, London, UK.ORCID 0000-0003-4362-940X
Mahnoor ArshadUniversity College London, London, UK.
Essam KerwashMedicines and Healthcare Products Regulatory Agency, London, UK.ORCID 0000-0003-4368-8565

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Due to limited non-clinical and clinical data, European guidance recommends to discontinue breastfeeding when taking albendazole. The aim of this study was to consider the use of PBPK modeling to support the expected exposure in breastfed infants. A fully mechanistic PBPK approach was used to provide quantitative predictions of albendazole and its main active metabolite, albendazole sulfoxide, concentrations in plasma and breast milk of lactating women. The model predicted the exposure in adults and the large food effect, however, it does not predict all the clinical data for the exposure in children. Milk/plasma ratio predictions were also largely over-predicted for this lipophilic compound, but not for the less lipophilic metabolite. Predictions using the observed ratio and a worse-case exposure based on C

Indexed as

AlbendazoleBreast FeedingMilk, HumanModels, BiologicalAdultAnthelminticsFemaleHumansInfantInfant, NewbornLactationAlbendazolealbendazole sulfoxideAnthelmintics

Identifiers

PMID39558864
PMCPMC11578140

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.